Clopidogrel Only Before Percutaneous Coronary Intervention or Before Every Coronarography?
Information source: Charles University, Czech Republic
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ischemic Heart Disease
Intervention: clopidogrel (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Charles University, Czech Republic Official(s) and/or principal investigator(s):
Petr Widimsky, MD, Principal Investigator, Affiliation: Charles University, Prague, Czech Republic
Zuzana Motovska, MD, Principal Investigator, Affiliation: Charles University, Prague, Czech Republic
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.
Clinical Details
Official title: 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.
Study design: Randomized, Open Label, Active Control, Parallel Assignment
Primary outcome: Primary end point was the first clinical occurrence of any of the following:
death / periprocedural myocardial infarction / stroke or transient ischemic attack / re-intervention
Secondary outcome: Secondary end-points were periprocedural troponin elevation (> 3x ULN), TIMI-flow
after PCI, bleeding complications and each individual component of the combined primary endpoint
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Charles University, Prague 10034, Czech Republic
Additional Information
Starting date: March 2006
Ending date: July 2007
Last updated: January 28, 2008
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