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CASTLE (Clopidogrel And Serum Troponin Level Elevation) (CASTLE)

Primary Purpose

Thrombosis

Status
Completed
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Clopidogrel
Clopidogrel
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi aventis administrative office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1

2

3

Arm Description

300-mg loading dose of clopidogrel given ≥ 6 and ≤ 24 hours before PCI

600-mg loading dose of clopidogrel given ≥ 6 hours and ≤ 24 before PCI.

600-mg loading dose of clopidogrel given immediately (≤ 45 minutes) before PCI.

Outcomes

Primary Outcome Measures

Incidence of post-percutaneous coronary intervention elevation of troponin T.

Secondary Outcome Measures

Adverse events.
Standard hematology and blood chemistry.

Full Information

First Posted
July 15, 2008
Last Updated
September 24, 2009
Sponsor
Sanofi
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00716924
Brief Title
CASTLE (Clopidogrel And Serum Troponin Level Elevation)
Acronym
CASTLE
Official Title
Clopidogrel 600 mg and 300 mg as a Loading Dose Prior to Percutaneous Coronary Intervention And Serum Troponin Level Elevation: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
300-mg loading dose of clopidogrel given ≥ 6 and ≤ 24 hours before PCI
Arm Title
2
Arm Type
Experimental
Arm Description
600-mg loading dose of clopidogrel given ≥ 6 hours and ≤ 24 before PCI.
Arm Title
3
Arm Type
Experimental
Arm Description
600-mg loading dose of clopidogrel given immediately (≤ 45 minutes) before PCI.
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
300 mg
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
600 mg
Primary Outcome Measure Information:
Title
Incidence of post-percutaneous coronary intervention elevation of troponin T.
Time Frame
At 6 and 12 months post-PCI
Secondary Outcome Measure Information:
Title
Adverse events.
Time Frame
From the beginning to the end of the study
Title
Standard hematology and blood chemistry.
Time Frame
At 6 and 12 months post-PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Diaz, Md
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi aventis administrative office
City
Mexico
Country
Mexico

12. IPD Sharing Statement

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CASTLE (Clopidogrel And Serum Troponin Level Elevation)

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