CASTLE (Clopidogrel And Serum Troponin Level Elevation)

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00716924

Acronym

CASTLE

Enrollment

155

Registered

2008-07-16

Start date

2004-05-31

Completion date

Unknown

Last updated

2009-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombosis

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.

Interventions

DRUGClopidogrel

300 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Incidence of post-percutaneous coronary intervention elevation of troponin T.	At 6 and 12 months post-PCI

Secondary

Measure	Time frame
Adverse events.	From the beginning to the end of the study
Standard hematology and blood chemistry.	At 6 and 12 months post-PCI

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026