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

Myocardial Infarction Clinical Trial

— CAPITAL-RCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01155635
• Other study ID #: C-417
• Status: Completed
• Phase: Phase 4
• First received: July 1, 2010
• Last updated: June 25, 2017
• Start date: July 2010
• Est. completion date: March 2017

Study information

• Verified date: June 2017
• Source: Kyoto University, Graduate School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 801
• Est. completion date: March 2017
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• Carvedilol
Use of Carvedilol with any dose
• No Carvedilol
No use of Carvedilol

Locations

Country	Name	City	State
Japan	Division of Cardiology, Kyoto University Hospital	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Takeshi Morimoto

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality	Death from any reason	6-year
Primary	Composite of death, myocardial infarction, acute coronary syndrome, heart failure hospitalization		6-year
Secondary	Cardiac death		6-year
Secondary	Sudden cardiac death		6-year
Secondary	Cardiovascular death		6-year
Secondary	Myocardial infarction		6-year
Secondary	Acute coronary syndrome		6-year
Secondary	Sustained ventricular tachycardia or ventricular fibrillation		6-year
Secondary	Heart failure hospitalization		6-year
Secondary	Stent thrombosis	Stent thrombosis defined by Academic Research Consortium	6-year
Secondary	Target-vessel revascularization		6-year
Secondary	Clinically-driven target-lesion revascularization		6-year
Secondary	Any coronary revascularization		6-year
Secondary	Any clinically-driven coronary revascularization		6-year
Secondary	Coronary artery bypass grafting		6-year
Secondary	Stroke	Any ischemic and hemorrhagic strokes excluding transient ischemic attacks	6-year
Secondary	Worsening of angina due to coronary spasm		6-year
Secondary	Bleeding complications	Bleeding complications defined by GUSTO and TIMI definitions	6-year
Secondary	Composite of death, myocardial infarction, stroke, acute coronary syndrome, heart failure hospitalization, any coronary revascularization		6-year
Secondary	Composite of cardiac death, myocardial infarction, acute coronary syndrome, heart failure hospitalization		6-year
Secondary	Composite of cardiovascular death, myocardial infarction, stroke		6-year