Carvedilol Post-intervention Long-term Administration in Large-scale Trial (CAPITAL-RCT)

Takeshi Morimoto

Status and phase: Completed; Phase 4

Conditions: Myocardial Infarction

Treatments: Drug: No Carvedilol; Drug: Carvedilol

Study type: Interventional

Funder types: Other

Identifiers

NCT01155635

C-417

Details and patient eligibility

About

The purpose of this study is to evaluate whether beta-blocker therapy improves 6-year clinical outcomes in patients with ST-segment elevation acute myocardial infarction and preserved left ventricular ejection fraction after primary percutaneous coronary intervention.

Full description

Beta-blocker therapy is recommended after ST-segment elevation acute myocardial infarction (STEMI) in the current guidelines although its efficacy in those patients who have undergone primary percutaneous coronary intervention (PCI) has not been adequately evaluated. The purpose of this study is to evaluate whether beta-blocker, carvedilol improves 6-year clinical outcomes in patients with STEMI and preserved left ventricular ejection fraction after primary PCI. The design of this study is multicenter, open-label, randomized controlled trial enrolling 1300 patients without any exclusion criteria.

Enrollment: 801 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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801 participants in 2 patient groups

Beta-blocker

Active Comparator group

Description:

Use of Carvedilol with any dose

Treatment:

Drug: Carvedilol

Non Beta-blocker

Active Comparator group

Description:

No use of Carvedilol

Treatment:

Drug: No Carvedilol