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

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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction
• Intervention / Treatment: Drug: Carvedilol; Drug: No Carvedilol

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 801
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Kyoto, Japan, 606-8507
    • Division of Cardiology, Kyoto University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Beta-blocker; Use of Carvedilol with any dose	Drug: Carvedilol; Use of Carvedilol with any dose
Active Comparator: Non Beta-blocker; No use of Carvedilol	Drug: No Carvedilol; No use of Carvedilol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality	Death from any reason	6-year
Composite of death, myocardial infarction, acute coronary syndrome, heart failure hospitalization		6-year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Takeshi Morimoto
• Investigators: Principal Investigator: Takeshi Kimura, MD, Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

Publications and helpful links

General Publications

• Watanabe H, Ozasa N, Morimoto T, Shiomi H, Bingyuan B, Suwa S, Nakagawa Y, Izumi C, Kadota K, Ikeguchi S, Hibi K, Furukawa Y, Kaji S, Suzuki T, Akao M, Inada T, Hayashi Y, Nanasato M, Okutsu M, Kametani R, Sone T, Sugimura Y, Kawai K, Abe M, Kaneko H, Nakamura S, Kimura T; CAPITAL-RCT investigators. Long-term use of carvedilol in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention. PLoS One. 2018 Aug 28;13(8):e0199347. doi: 10.1371/journal.pone.0199347. eCollection 2018.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: July 1, 2010
• First Submitted That Met QC Criteria: July 1, 2010
• First Posted (Estimate): July 2, 2010

Study Record Updates

• Last Update Posted (Actual): June 27, 2017
• Last Update Submitted That Met QC Criteria: June 25, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Myocardial infarction; Percutaneous coronary intervention; Adrenergic beta-Antagonists
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Protective Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Antioxidants; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Carvedilol
• Other Study ID Numbers: C-417