Clopidogrel Only Before Percutaneous Coronary Intervention or Before Every Coronarography?
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.
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2006
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 5, 2007
CompletedFirst Posted
Study publicly available on registry
February 7, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedJanuary 29, 2008
August 1, 2007
1.3 years
February 5, 2007
January 28, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (2)
A
ACTIVE COMPARATOR"nonselective" - clopidogrel 600 mg \>6 hours before coronary angiography;
B
ACTIVE COMPARATOR"selective" - clopidogrel 600 mg in the cath-lab after coronary angiography, only in case of percutaneous coronary intervention
Interventions
To compare two different clopidogrel regimens on the outcomes of patients undergoing elective coronary angiography ± ad-hoc percutaneous coronary intervention
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Elective CAG for suspected or proven coronary artery disease (stable forms or fully stabilized acute coronary syndrome)
- Signed written informed consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Charles University
Prague, 10034, Czechia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Petr Widimsky, MD
Charles University, Prague, Czech Republic
- PRINCIPAL INVESTIGATOR
Zuzana Motovska, MD
Charles University, Prague, Czech Republic
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 5, 2007
First Posted
February 7, 2007
Study Start
March 1, 2006
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
January 29, 2008
Record last verified: 2007-08