Skip to main content
OpenTrials
Completed

NCT Number: NCT00716924

CASTLE (Clopidogrel And Serum Troponin Level Elevation)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Thrombosis Cardiovascular Diseases Embolism and Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi aventis administrative office

México, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

clopidogrel

Drug

300 mg

Primary outcomes

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

    Time frame: At 6 and 12 months post-PCI

Secondary outcomes

  1. Adverse events.

    Time frame: From the beginning to the end of the study

  2. Standard hematology and blood chemistry.

    Time frame: At 6 and 12 months post-PCI

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

Clopidogrel 600 mg and 300 mg as a Loading Dose Prior to Percutaneous Coronary Intervention And Serum Troponin Level Elevation: A Pilot Study

Acronym: CASTLE

Important dates

Study start
2004
Primary completion
2006
First posted
Jul 16, 2008
Registry last updated
Sep 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.