Carvedilol Post-intervention Long-term Administration in Large-scale Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 7 January 2013
• Main ID: NCT01155635
• Date of registration: 01/07/2010
• Primary sponsor: Takeshi Morimoto
• Public title: Carvedilol Post-intervention Long-term Administration in Large-scale Trial CAPITAL-RCT
• Scientific title: Carvedilol Post-intervention Long-term Administration in Large-scale Randomized Controlled Trial
• Date of first enrolment: July 2010
• Target sample size: 1300
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01155635
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Japan

Contacts

• Name: Takeshi Kimura, MD

• Name: Takeshi Kimura, MD

• Name: Takeshi Kimura, MD
• Affiliation: Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with STEMI after primary PCI

- Patients with left ventricular ejection fraction more than or equal to 40%

Exclusion Criteria:

- Patients with left ventricular ejection fraction less than 40%

- Patients with contraindication for beta-blocker

- Patients with implantable cardioverter defibrillators

- Patients with end-stage malignancy



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Myocardial Infarction

Intervention(s)

Drug: Carvedilol

Drug: No Carvedilol

Primary Outcome(s)

All cause mortality [Time Frame: 6-year]

Composite of death, myocardial infarction, acute coronary syndrome, heart failure hospitalization [Time Frame: 6-year]

Secondary Outcome(s)

Acute coronary syndrome [Time Frame: 6-year]

Any clinically-driven coronary revascularization [Time Frame: 6-year]

Any coronary revascularization [Time Frame: 6-year]

Bleeding complications [Time Frame: 6-year]

Cardiac death [Time Frame: 6-year]

Cardiovascular death [Time Frame: 6-year]

Clinically-driven target-lesion revascularization [Time Frame: 6-year]

Composite of cardiac death, myocardial infarction, acute coronary syndrome, heart failure hospitalization [Time Frame: 6-year]

Composite of cardiovascular death, myocardial infarction, stroke [Time Frame: 6-year]

Composite of death, myocardial infarction, stroke, acute coronary syndrome, heart failure hospitalization, any coronary revascularization [Time Frame: 6-year]

Coronary artery bypass grafting [Time Frame: 6-year]

Heart failure hospitalization [Time Frame: 6-year]

Myocardial infarction [Time Frame: 6-year]

Stent thrombosis [Time Frame: 6-year]

Stroke [Time Frame: 6-year]

Sudden cardiac death [Time Frame: 6-year]

Sustained ventricular tachycardia or ventricular fibrillation [Time Frame: 6-year]

Target-vessel revascularization [Time Frame: 6-year]

Worsening of angina due to coronary spasm [Time Frame: 6-year]

Secondary ID(s)

C-417

Source(s) of Monetary Support

Please refer to primary and secondary sponsors