Clopidogrel Only Before Percutaneous Coronary Intervention or Before Every Coronarography?

Phase 3

Completed

• Conditions: Ischemic Heart Disease
• Interventions: Drug: clopidogrel

• Registration Number: NCT00432120
• Lead Sponsor: Charles University, Czech Republic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2007-02-05
• Study First Submitted QC: 2007-02-05
• Study First Posted: 2007-02-07
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2007-08
• Last Update Submitted: 2008-01-28
• Last Update Posted: 2008-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	clopidogrel	"nonselective" - clopidogrel 600 mg \>6 hours before coronary angiography;
B	clopidogrel	"selective" - clopidogrel 600 mg in the cath-lab after coronary angiography, only in case of percutaneous coronary intervention

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Charles University; 🇨🇿 Prague, Czech Republic