Ischemic Heart Disease
Conditions
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.
Interventions
DRUGclopidogrel
To compare two different clopidogrel regimens on the outcomes of patients undergoing elective coronary angiography ± ad-hoc percutaneous coronary intervention
Sponsors
Charles University, Czech Republic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
1. Age ≥ 18 years 2. Elective CAG for suspected or proven coronary artery disease (stable forms or fully stabilized acute coronary syndrome) 3. Signed written informed consent
Exclusion criteria
1. Thienopyridine treatment in previous two weeks 2. Contraindication for clopidogrel 3. CAG scheduled less than 6 hours after potential randomization 4. Clinically significant bleeding (i.e. with hemoglobin fall by \> 50 g/l and/or requiring transfusions or surgery) in previous 3 months.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Czechia
Outcome results
None listed