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

Status

Completed

Conditions

Intervention / Treatment

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, 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
Drug: Clopidogrel
300 mg
Drug: Clopidogrel
600 mg
Experimental: 2
600-mg loading dose of clopidogrel given ≥ 6 hours and ≤ 24 before PCI.
Drug: Clopidogrel
300 mg
Drug: Clopidogrel
600 mg
Experimental: 3
600-mg loading dose of clopidogrel given immediately (≤ 45 minutes) before PCI.
Drug: Clopidogrel
300 mg
Drug: Clopidogrel
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

Sanofi

Collaborators

Bristol-Myers Squibb

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

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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