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Greater differences between randomized patients than previously anticipated
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The purpose of the study is to determine whether administration of 150 mg clopidogrel is effective in reducing the one-year incidence of thromboischemic events in patients with high on-clopidogrel platelet reactivity compared to 75 mg clopidogrel after elective percutaneous coronary intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | No Intervention | Patients who show adequate response to 600 mg loading dose of clopidogrel and receive standard 1x75 mg clopidogrel | |
| 2 | Experimental | Patients who show suboptimal response to 600 mg loading dose of clopidogrel and receive 1x150 mg clopidogrel for 28 days |
|
| 3 | Active Comparator | Patients who show suboptimal response to 600 mg loading dose of clopidogrel and receive 1x75 mg clopidogrel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clopidogrel | Drug | 150 mg maintenance dose (2 capsules of 75 mg clopidogrel) for 28 days followed by standard 75 mg clopidogrel for one year |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Academic Research Consortium (ARC) definite / probable stent thrombosis | 12 months | |
| Cardiac death and non-fatal myocardial infarction | 12 months | |
| Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation or TIMI major/minor bleeding |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivan G Horvath, MD PhD | Heart Institute, University of Pécs, HUNGARY | Principal Investigator |
| Daniel Aradi, MD | Heart Institute, University of Pécs, HUNGARY | Study Director |
| Andras Komocsi, MD PhD | Heart Institute, University of Pécs, HUNGARY | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Institute, University of Pécs, Dept. of Interventional Cardiology | Pécs | 7624 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21902692 | Derived | Aradi D, Rideg O, Vorobcsuk A, Magyarlaki T, Magyari B, Konyi A, Pinter T, Horvath IG, Komocsi A. Justification of 150 mg clopidogrel in patients with high on-clopidogrel platelet reactivity. Eur J Clin Invest. 2012 Apr;42(4):384-92. doi: 10.1111/j.1365-2362.2011.02594.x. Epub 2011 Sep 9. | |
| 21806387 | Derived |
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| clopidogrel plus placebo | Drug | 75 mg maintenance dose (one capsule of 75 mg clopidogrel and one capsule placebo) for 28 days followed by standard 75 mg clopidogrel for one year |
|
| 12 months |
| 5 microM ADP-induced platelet aggregation assessed by light transmission aggregometer | 25 +/-2 days |
| VASP-PRI | 25 +/-2 days |
| Rideg O, Komocsi A, Magyarlaki T, Tokes-Fuzesi M, Miseta A, Kovacs GL, Aradi D. Impact of genetic variants on post-clopidogrel platelet reactivity in patients after elective percutaneous coronary intervention. Pharmacogenomics. 2011 Sep;12(9):1269-80. doi: 10.2217/pgs.11.73. Epub 2011 Aug 1. |
| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |