Clopidogrel Only Before Percutaneous Coronary Intervention or Before Every Coronarography?

Study Overview
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Brief Summary
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Clopidogrel pre-treatment before planned percutaneous coronary intervention was proved to reduce periprocedural complications. However, the vast majority of patients in the current interventional cardiology practice do not undergo planned PCI, but rather ad-hoc PCI performed immediately after coronary angiography . Whether clopidogrel should be administered as pre-treatment to all patients undergoing elective CAG with the aim to ensure therapeutic levels at the time of possible ad-hoc PCI is not known.

Official Title
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Clopidogrel Loading Dose for ad-Hoc Percutaneous Coronary Intervention Immediately Following Elective Coronary Angiography: Randomized Multicenter Trial Comparing Pre-Treatment > 6 Hours Before Every Angiography vs. Cath-Lab Administration After Angiography (Just Before Intervention): the PRAGUE-8 Trial.

Conditions
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Ischemic Heart Disease

Intervention / Treatment
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* Drug: clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Elective CAG for suspected or proven coronary artery disease (stable forms or fully stabilized acute coronary syndrome) Signed written informed consent Exclusion Criteria: Thienopyridine treatment in previous two weeks Contraindication for clopidogrel CAG scheduled less than 6 hours after potential randomization Clinically significant bleeding (i.e. with hemoglobin fall by > 50 g/l and/or requiring transfusions or surgery) in previous 3 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>nonselective - clopidogrel 600 mg >6 hours before coronary angiography; | Drug: clopidogrel<br>* To compare two different clopidogrel regimens on the outcomes of patients undergoing elective coronary angiography ± ad-hoc percutaneous coronary intervention<br>|
| Active Comparator: B<br>selective - clopidogrel 600 mg in the cath-lab after coronary angiography, only in case of percutaneous coronary intervention | Drug: clopidogrel<br>* To compare two different clopidogrel regimens on the outcomes of patients undergoing elective coronary angiography ± ad-hoc percutaneous coronary intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary end point was the first clinical occurrence of any of the following: death / periprocedural myocardial infarction / stroke or transient ischemic attack / re-intervention |  | within 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary end-points were periprocedural troponin elevation (> 3x ULN), TIMI-flow after PCI, bleeding complications and each individual component of the combined primary endpoint |  | within 7 day |