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.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Locations
- 1
- Primary Endpoint
- Primary end point was the first clinical occurrence of any of the following: death / periprocedural myocardial infarction / stroke or transient ischemic attack / re-intervention
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
A
"nonselective" - clopidogrel 600 mg >6 hours before coronary angiography;
Intervention: clopidogrel (Drug)
B
"selective" - clopidogrel 600 mg in the cath-lab after coronary angiography, only in case of percutaneous coronary intervention
Intervention: clopidogrel (Drug)
Outcomes
Primary Outcomes
Primary end point was the first clinical occurrence of any of the following: death / periprocedural myocardial infarction / stroke or transient ischemic attack / re-intervention
Time Frame: within 7 days
Secondary Outcomes
- 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)