- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00716924
CASTLE (Clopidogrel And Serum Troponin Level Elevation) (CASTLE)
September 24, 2009 updated by: Sanofi
Clopidogrel 600 mg and 300 mg as a Loading Dose Prior to Percutaneous Coronary Intervention And Serum Troponin Level Elevation: A Pilot Study
Primary Objective: To test if 600 mg of clopidogrel loading dose administered ≥ 6 and ≤ 24 hours prior to PCI produce a greater decrease of periprocedural release of biochemical markers (CK, CK-MB, and troponin-T and/or I) of myocardial necrosis, compared to 300 mg loading dose, given ≥ 6 and ≤ 24 hours prior to PCI or 600 mg loading dose of clopidogrel, administered immediately (≤ 45 minutes) before PCI.
Study Overview
Study Type
Interventional
Enrollment (Actual)
155
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Mexico, Mexico
- Sanofi aventis administrative office
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients having symptomatic coronary artery disease with objective evidence of ischemia (eg, symptoms of angina pectoris, positive stress test results or dynamic electrocardiographic (ECG) changes).
- Patients undergoing stent implantation
Exclusion Criteria:
- Any known contraindication to the use of aspirin or clopidogrel.
- Patients receiving clopidogrel within 10 days, thrombolytics within 24 hours or receiving oral anticoagulation therapy
- Elective administration of IIb/IIIa inhibitors.
- Cardiogenic shock
- Acute MI< 24 hours
- BP systolic <100 mmHg
- Left ventricular ejection fraction < 30%
- Heart failure, NYHA class III or IV
- Severe renal insufficiency (creatinine > 3.0 mg/dL)
- Platelet count <100,000/mm³
- Target lesion in a venous bypass graft
- Target lesion in a chronic occlusion
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
300-mg loading dose of clopidogrel given ≥ 6 and ≤ 24 hours before PCI
|
300 mg
600 mg
|
Experimental: 2
600-mg loading dose of clopidogrel given ≥ 6 hours and ≤ 24 before PCI.
|
300 mg
600 mg
|
Experimental: 3
600-mg loading dose of clopidogrel given immediately (≤ 45 minutes) before PCI.
|
300 mg
600 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of post-percutaneous coronary intervention elevation of troponin T.
Time Frame: At 6 and 12 months post-PCI
|
At 6 and 12 months post-PCI
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events.
Time Frame: From the beginning to the end of the study
|
From the beginning to the end of the study
|
Standard hematology and blood chemistry.
Time Frame: At 6 and 12 months post-PCI
|
At 6 and 12 months post-PCI
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Judith Diaz, Md, Sanofi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2004
Primary Completion (Actual)
February 1, 2006
Study Registration Dates
First Submitted
July 15, 2008
First Submitted That Met QC Criteria
July 15, 2008
First Posted (Estimate)
July 16, 2008
Study Record Updates
Last Update Posted (Estimate)
September 25, 2009
Last Update Submitted That Met QC Criteria
September 24, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Embolism and Thrombosis
- Thrombosis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Platelet Aggregation Inhibitors
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Clopidogrel
Other Study ID Numbers
- L_9317
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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