Effects of P2Y12 receptor inhibition with or without aspirin on hemostatic system activation: a randomized trial in healthy subjects
Essentials In acute coronary syndromes, dual antiplatelet therapy inhibits platelets but confers a bleeding risk. Healthy male volunteers received clopidogrel or ticagrelor plus aspirin or clopidogrel or ticagrelor alone. The decrease in β‐thromboglobulin in shed blood was comparable after single an...
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| Published in | Journal of thrombosis and haemostasis Vol. 14; no. 2; pp. 273 - 281 |
|---|---|
| Main Authors | , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
Elsevier Limited
01.02.2016
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| Subjects | |
| Online Access | Get full text |
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| Abstract | Essentials
In acute coronary syndromes, dual antiplatelet therapy inhibits platelets but confers a bleeding risk.
Healthy male volunteers received clopidogrel or ticagrelor plus aspirin or clopidogrel or ticagrelor alone.
The decrease in β‐thromboglobulin in shed blood was comparable after single and dual antiplatelet therapy.
We hypothesize that patients with acute coronary syndromes may not require dual antiplatelet therapy.
Summary
Background
Dual antiplatelet therapy with a P2Y12 inhibitor and aspirin is standard in acute coronary syndromes. Dual antiplatelet therapy causes more bleeding than single antiplatelet therapy with a P2Y12 inhibitor.
Objectives
To compare the effects of dual and single antiplatelet therapies on hemostatic system activation.
Patients/Methods
In a randomized, parallel‐group, double‐blind, placebo‐controlled study, 44 healthy volunteers received clopidogrel (600 mg, then 150 mg d–1) and aspirin (100 mg d–1) or placebo for 7 days; An additional 44 volunteers received single‐dose ticagrelor (180 mg) and aspirin (300 mg) or placebo. β‐Thromboglobulin (β‐TG [IU L–1]) and prothrombin fragment 1.2 (f1.2 [nmol L–1]) were measured in blood obtained from bleeding time incisions. Data are given as geometric mean ratio (GMR [95% confidence interval]) to describe the differences in the first 2 h and as mean differences (Δ [95% confidence interval]) in area under the curve (AUC) to discriminate differences in effects over the total observation time.
Results
Clopidogrel plus aspirin and clopidogrel plus placebo reduced β‐TG by a GMR of 0.51 (0.42–0.63) and 0.54 (0.46–0.64) at 2 h. Ticagrelor plus aspirin and ticagrelor plus placebo decreased β‐TG by a GMR of 0.38 (0.26–0.57) and 0.47 (0.31–0.72). Ticagrelor plus aspirin and ticagrelor plus placebo reduced f1.2 by a GMR of 0.58 (0.45–0.75) and 0.55 (0.38–0.80); clopidogrel did not. Over 24 h, no difference in β‐TG occurred between clopidogrel plus aspirin and clopidogrel plus placebo (ΔAUC = −2.9 [−9.9 to 4.1]) or between ticagrelor plus aspirin and ticagrelor plus placebo (ΔAUC = −3.5 [−11.8 to 4.7]). No difference in f1.2 occurred between clopidogrel plus aspirin and clopidogrel plus placebo (ΔAUC = −4.2 [−10.2 to 1.8]) or between ticagrelor plus aspirin and ticagrelor plus placebo (ΔAUC = −3.6 [−10.9 to 3.7]).
Conclusions
P2Y12 inhibitor monotherapy and dual antiplatelet therapy inhibit hemostatic system activation to a comparable extent. |
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| AbstractList | Essentials In acute coronary syndromes, dual antiplatelet therapy inhibits platelets but confers a bleeding risk. Healthy male volunteers received clopidogrel or ticagrelor plus aspirin or clopidogrel or ticagrelor alone. The decrease in [beta]-thromboglobulin in shed blood was comparable after single and dual antiplatelet therapy. We hypothesize that patients with acute coronary syndromes may not require dual antiplatelet therapy. Summary Background Dual antiplatelet therapy with a P2Y12 inhibitor and aspirin is standard in acute coronary syndromes. Dual antiplatelet therapy causes more bleeding than single antiplatelet therapy with a P2Y12 inhibitor. Objectives To compare the effects of dual and single antiplatelet therapies on hemostatic system activation. Patients/Methods In a randomized, parallel-group, double-blind, placebo-controlled study, 44 healthy volunteers received clopidogrel (600 mg, then 150 mg d-1) and aspirin (100 mg d-1) or placebo for 7 days; An additional 44 volunteers received single-dose ticagrelor (180 mg) and aspirin (300 mg) or placebo. [beta]-Thromboglobulin ([beta]-TG [IU L-1]) and prothrombin fragment 1.2 (f1.2 [nmol L-1]) were measured in blood obtained from bleeding time incisions. Data are given as geometric mean ratio (GMR [95% confidence interval]) to describe the differences in the first 2 h and as mean differences ([Delta] [95% confidence interval]) in area under the curve (AUC) to discriminate differences in effects over the total observation time. Results Clopidogrel plus aspirin and clopidogrel plus placebo reduced [beta]-TG by a GMR of 0.51 (0.42-0.63) and 0.54 (0.46-0.64) at 2 h. Ticagrelor plus aspirin and ticagrelor plus placebo decreased [beta]-TG by a GMR of 0.38 (0.26-0.57) and 0.47 (0.31-0.72). Ticagrelor plus aspirin and ticagrelor plus placebo reduced f1.2 by a GMR of 0.58 (0.45-0.75) and 0.55 (0.38-0.80); clopidogrel did not. Over 24 h, no difference in [beta]-TG occurred between clopidogrel plus aspirin and clopidogrel plus placebo ([Delta]AUC = -2.9 [-9.9 to 4.1]) or between ticagrelor plus aspirin and ticagrelor plus placebo ([Delta]AUC = -3.5 [-11.8 to 4.7]). No difference in f1.2 occurred between clopidogrel plus aspirin and clopidogrel plus placebo ([Delta]AUC = -4.2 [-10.2 to 1.8]) or between ticagrelor plus aspirin and ticagrelor plus placebo ([Delta]AUC = -3.6 [-10.9 to 3.7]). Conclusions P2Y12 inhibitor monotherapy and dual antiplatelet therapy inhibit hemostatic system activation to a comparable extent. Essentials In acute coronary syndromes, dual antiplatelet therapy inhibits platelets but confers a bleeding risk. Healthy male volunteers received clopidogrel or ticagrelor plus aspirin or clopidogrel or ticagrelor alone. The decrease in β‐thromboglobulin in shed blood was comparable after single and dual antiplatelet therapy. We hypothesize that patients with acute coronary syndromes may not require dual antiplatelet therapy. Summary Background Dual antiplatelet therapy with a P2Y12 inhibitor and aspirin is standard in acute coronary syndromes. Dual antiplatelet therapy causes more bleeding than single antiplatelet therapy with a P2Y12 inhibitor. Objectives To compare the effects of dual and single antiplatelet therapies on hemostatic system activation. Patients/Methods In a randomized, parallel‐group, double‐blind, placebo‐controlled study, 44 healthy volunteers received clopidogrel (600 mg, then 150 mg d–1) and aspirin (100 mg d–1) or placebo for 7 days; An additional 44 volunteers received single‐dose ticagrelor (180 mg) and aspirin (300 mg) or placebo. β‐Thromboglobulin (β‐TG [IU L–1]) and prothrombin fragment 1.2 (f1.2 [nmol L–1]) were measured in blood obtained from bleeding time incisions. Data are given as geometric mean ratio (GMR [95% confidence interval]) to describe the differences in the first 2 h and as mean differences (Δ [95% confidence interval]) in area under the curve (AUC) to discriminate differences in effects over the total observation time. Results Clopidogrel plus aspirin and clopidogrel plus placebo reduced β‐TG by a GMR of 0.51 (0.42–0.63) and 0.54 (0.46–0.64) at 2 h. Ticagrelor plus aspirin and ticagrelor plus placebo decreased β‐TG by a GMR of 0.38 (0.26–0.57) and 0.47 (0.31–0.72). Ticagrelor plus aspirin and ticagrelor plus placebo reduced f1.2 by a GMR of 0.58 (0.45–0.75) and 0.55 (0.38–0.80); clopidogrel did not. Over 24 h, no difference in β‐TG occurred between clopidogrel plus aspirin and clopidogrel plus placebo (ΔAUC = −2.9 [−9.9 to 4.1]) or between ticagrelor plus aspirin and ticagrelor plus placebo (ΔAUC = −3.5 [−11.8 to 4.7]). No difference in f1.2 occurred between clopidogrel plus aspirin and clopidogrel plus placebo (ΔAUC = −4.2 [−10.2 to 1.8]) or between ticagrelor plus aspirin and ticagrelor plus placebo (ΔAUC = −3.6 [−10.9 to 3.7]). Conclusions P2Y12 inhibitor monotherapy and dual antiplatelet therapy inhibit hemostatic system activation to a comparable extent. ESSENTIALS: In acute coronary syndromes, dual antiplatelet therapy inhibits platelets but confers a bleeding risk. Healthy male volunteers received clopidogrel or ticagrelor plus aspirin or clopidogrel or ticagrelor alone. The decrease in β-thromboglobulin in shed blood was comparable after single and dual antiplatelet therapy. We hypothesize that patients with acute coronary syndromes may not require dual antiplatelet therapy. Dual antiplatelet therapy with a P2Y12 inhibitor and aspirin is standard in acute coronary syndromes. Dual antiplatelet therapy causes more bleeding than single antiplatelet therapy with a P2Y12 inhibitor. To compare the effects of dual and single antiplatelet therapies on hemostatic system activation. In a randomized, parallel-group, double-blind, placebo-controlled study, 44 healthy volunteers received clopidogrel (600 mg, then 150 mg d(-1) ) and aspirin (100 mg d(-1) ) or placebo for 7 days; An additional 44 volunteers received single-dose ticagrelor (180 mg) and aspirin (300 mg) or placebo. β-Thromboglobulin (β-TG [IU L(-1) ]) and prothrombin fragment 1.2 (f1.2 [nmol L(-1) ]) were measured in blood obtained from bleeding time incisions. Data are given as geometric mean ratio (GMR [95% confidence interval]) to describe the differences in the first 2 h and as mean differences (Δ [95% confidence interval]) in area under the curve (AUC) to discriminate differences in effects over the total observation time. Clopidogrel plus aspirin and clopidogrel plus placebo reduced β-TG by a GMR of 0.51 (0.42-0.63) and 0.54 (0.46-0.64) at 2 h. Ticagrelor plus aspirin and ticagrelor plus placebo decreased β-TG by a GMR of 0.38 (0.26-0.57) and 0.47 (0.31-0.72). Ticagrelor plus aspirin and ticagrelor plus placebo reduced f1.2 by a GMR of 0.58 (0.45-0.75) and 0.55 (0.38-0.80); clopidogrel did not. Over 24 h, no difference in β-TG occurred between clopidogrel plus aspirin and clopidogrel plus placebo (ΔAUC = -2.9 [-9.9 to 4.1]) or between ticagrelor plus aspirin and ticagrelor plus placebo (ΔAUC = -3.5 [-11.8 to 4.7]). No difference in f1.2 occurred between clopidogrel plus aspirin and clopidogrel plus placebo (ΔAUC = -4.2 [-10.2 to 1.8]) or between ticagrelor plus aspirin and ticagrelor plus placebo (ΔAUC = -3.6 [-10.9 to 3.7]). P2Y12 inhibitor monotherapy and dual antiplatelet therapy inhibit hemostatic system activation to a comparable extent. ESSENTIALS: In acute coronary syndromes, dual antiplatelet therapy inhibits platelets but confers a bleeding risk. Healthy male volunteers received clopidogrel or ticagrelor plus aspirin or clopidogrel or ticagrelor alone. The decrease in β-thromboglobulin in shed blood was comparable after single and dual antiplatelet therapy. We hypothesize that patients with acute coronary syndromes may not require dual antiplatelet therapy.UNLABELLEDESSENTIALS: In acute coronary syndromes, dual antiplatelet therapy inhibits platelets but confers a bleeding risk. Healthy male volunteers received clopidogrel or ticagrelor plus aspirin or clopidogrel or ticagrelor alone. The decrease in β-thromboglobulin in shed blood was comparable after single and dual antiplatelet therapy. We hypothesize that patients with acute coronary syndromes may not require dual antiplatelet therapy.Dual antiplatelet therapy with a P2Y12 inhibitor and aspirin is standard in acute coronary syndromes. Dual antiplatelet therapy causes more bleeding than single antiplatelet therapy with a P2Y12 inhibitor.BACKGROUNDDual antiplatelet therapy with a P2Y12 inhibitor and aspirin is standard in acute coronary syndromes. Dual antiplatelet therapy causes more bleeding than single antiplatelet therapy with a P2Y12 inhibitor.To compare the effects of dual and single antiplatelet therapies on hemostatic system activation.OBJECTIVESTo compare the effects of dual and single antiplatelet therapies on hemostatic system activation.In a randomized, parallel-group, double-blind, placebo-controlled study, 44 healthy volunteers received clopidogrel (600 mg, then 150 mg d(-1) ) and aspirin (100 mg d(-1) ) or placebo for 7 days; An additional 44 volunteers received single-dose ticagrelor (180 mg) and aspirin (300 mg) or placebo. β-Thromboglobulin (β-TG [IU L(-1) ]) and prothrombin fragment 1.2 (f1.2 [nmol L(-1) ]) were measured in blood obtained from bleeding time incisions. Data are given as geometric mean ratio (GMR [95% confidence interval]) to describe the differences in the first 2 h and as mean differences (Δ [95% confidence interval]) in area under the curve (AUC) to discriminate differences in effects over the total observation time.PATIENTS/METHODSIn a randomized, parallel-group, double-blind, placebo-controlled study, 44 healthy volunteers received clopidogrel (600 mg, then 150 mg d(-1) ) and aspirin (100 mg d(-1) ) or placebo for 7 days; An additional 44 volunteers received single-dose ticagrelor (180 mg) and aspirin (300 mg) or placebo. β-Thromboglobulin (β-TG [IU L(-1) ]) and prothrombin fragment 1.2 (f1.2 [nmol L(-1) ]) were measured in blood obtained from bleeding time incisions. Data are given as geometric mean ratio (GMR [95% confidence interval]) to describe the differences in the first 2 h and as mean differences (Δ [95% confidence interval]) in area under the curve (AUC) to discriminate differences in effects over the total observation time.Clopidogrel plus aspirin and clopidogrel plus placebo reduced β-TG by a GMR of 0.51 (0.42-0.63) and 0.54 (0.46-0.64) at 2 h. Ticagrelor plus aspirin and ticagrelor plus placebo decreased β-TG by a GMR of 0.38 (0.26-0.57) and 0.47 (0.31-0.72). Ticagrelor plus aspirin and ticagrelor plus placebo reduced f1.2 by a GMR of 0.58 (0.45-0.75) and 0.55 (0.38-0.80); clopidogrel did not. Over 24 h, no difference in β-TG occurred between clopidogrel plus aspirin and clopidogrel plus placebo (ΔAUC = -2.9 [-9.9 to 4.1]) or between ticagrelor plus aspirin and ticagrelor plus placebo (ΔAUC = -3.5 [-11.8 to 4.7]). No difference in f1.2 occurred between clopidogrel plus aspirin and clopidogrel plus placebo (ΔAUC = -4.2 [-10.2 to 1.8]) or between ticagrelor plus aspirin and ticagrelor plus placebo (ΔAUC = -3.6 [-10.9 to 3.7]).RESULTSClopidogrel plus aspirin and clopidogrel plus placebo reduced β-TG by a GMR of 0.51 (0.42-0.63) and 0.54 (0.46-0.64) at 2 h. Ticagrelor plus aspirin and ticagrelor plus placebo decreased β-TG by a GMR of 0.38 (0.26-0.57) and 0.47 (0.31-0.72). Ticagrelor plus aspirin and ticagrelor plus placebo reduced f1.2 by a GMR of 0.58 (0.45-0.75) and 0.55 (0.38-0.80); clopidogrel did not. Over 24 h, no difference in β-TG occurred between clopidogrel plus aspirin and clopidogrel plus placebo (ΔAUC = -2.9 [-9.9 to 4.1]) or between ticagrelor plus aspirin and ticagrelor plus placebo (ΔAUC = -3.5 [-11.8 to 4.7]). No difference in f1.2 occurred between clopidogrel plus aspirin and clopidogrel plus placebo (ΔAUC = -4.2 [-10.2 to 1.8]) or between ticagrelor plus aspirin and ticagrelor plus placebo (ΔAUC = -3.6 [-10.9 to 3.7]).P2Y12 inhibitor monotherapy and dual antiplatelet therapy inhibit hemostatic system activation to a comparable extent.CONCLUSIONSP2Y12 inhibitor monotherapy and dual antiplatelet therapy inhibit hemostatic system activation to a comparable extent. |
| Author | Eichinger, S. Wolzt, M. Kyrle, P. A. Kaider, A. Kollars, M. Traby, L. |
| Author_xml | – sequence: 1 givenname: L. surname: Traby fullname: Traby, L. organization: Medical University of Vienna – sequence: 2 givenname: M. surname: Kollars fullname: Kollars, M. organization: Medical University of Vienna – sequence: 3 givenname: A. surname: Kaider fullname: Kaider, A. organization: Medical University of Vienna – sequence: 4 givenname: S. surname: Eichinger fullname: Eichinger, S. organization: Medical University of Vienna – sequence: 5 givenname: M. surname: Wolzt fullname: Wolzt, M. organization: Medical University of Vienna – sequence: 6 givenname: P. A. surname: Kyrle fullname: Kyrle, P. A. organization: Medical University of Vienna |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/26663880$$D View this record in MEDLINE/PubMed |
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| Copyright | 2015 International Society on Thrombosis and Haemostasis 2015 International Society on Thrombosis and Haemostasis. Copyright © 2016 International Society on Thrombosis and Haemostasis |
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| Snippet | Essentials
In acute coronary syndromes, dual antiplatelet therapy inhibits platelets but confers a bleeding risk.
Healthy male volunteers received clopidogrel... ESSENTIALS: In acute coronary syndromes, dual antiplatelet therapy inhibits platelets but confers a bleeding risk. Healthy male volunteers received clopidogrel... Essentials In acute coronary syndromes, dual antiplatelet therapy inhibits platelets but confers a bleeding risk. Healthy male volunteers received clopidogrel... |
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| SubjectTerms | Acute coronary syndromes Adenosine - administration & dosage Adenosine - adverse effects Adenosine - analogs & derivatives Adolescent Adult Angina pectoris Area Under Curve Aspirin Aspirin - administration & dosage Aspirin - adverse effects Austria beta-Thromboglobulin - metabolism Biomarkers - blood Bleeding Time Blood Platelets - drug effects Blood Platelets - metabolism clopidogrel Confidence intervals Double-Blind Method Healthy Volunteers Heart attacks Hemostasis - drug effects Humans Male Middle Aged Peptide Fragments - blood platelet aggregation inhibitors Platelet Aggregation Inhibitors - administration & dosage Platelet Aggregation Inhibitors - adverse effects Predictive Value of Tests Prothrombin Purinergic P2Y Receptor Antagonists - administration & dosage Purinergic P2Y Receptor Antagonists - adverse effects Receptors, Purinergic P2Y12 - drug effects Receptors, Purinergic P2Y12 - metabolism ROC Curve ticagrelor Ticlopidine - administration & dosage Ticlopidine - adverse effects Ticlopidine - analogs & derivatives Time Factors Young Adult |
| Title | Effects of P2Y12 receptor inhibition with or without aspirin on hemostatic system activation: a randomized trial in healthy subjects |
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