Clopidogrel Only Before Percutaneous Coronary Intervention or Before Every Coronarography?

Ischemic Heart Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00432120
• Other study ID #: PRAGUE 8
• Status: Completed
• Phase: Phase 3
• First received: February 5, 2007
• Last updated: January 28, 2008
• Start date: March 2006
• Est. completion date: July 2007

Study information

• Verified date: August 2007
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Drug:
• clopidogrel
To compare two different clopidogrel regimens on the outcomes of patients undergoing elective coronary angiography ± ad-hoc percutaneous coronary intervention

Locations

Country	Name	City	State
Czech Republic	Charles University	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes