Clinical trial NCT01155635: Carvedilol Post-intervention Long-term Administration in Large-scale Trial
Official title: Carvedilol Post-intervention Long-term Administration in Large-scale Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction
Keywords: Myocardial infarction
Adrenergic beta-Antagonists
Percutaneous coronary intervention
Lead sponsor: Kyoto University, Graduate School of Medicine
Sponsor class: OTHER
First posted: 2010-07-02
Enrollment: 801
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: All cause mortality
timeFrame: 6-year
measure: Composite of death, myocardial infarction, acute coronary syndrome, heart failure hospitalization
timeFrame: 6-year
Secondary outcomes:
measure: Cardiac death
timeFrame: 6-year
measure: Sudden cardiac death
timeFrame: 6-year
measure: Cardiovascular death
timeFrame: 6-year
measure: Myocardial infarction
timeFrame: 6-year
measure: Acute coronary syndrome
timeFrame: 6-year
measure: Sustained ventricular tachycardia or ventricular fibrillation
timeFrame: 6-year
measure: Heart failure hospitalization
timeFrame: 6-year
measure: Stent thrombosis
timeFrame: 6-year
measure: Target-vessel revascularization
timeFrame: 6-year
measure: Clinically-driven target-lesion revascularization
timeFrame: 6-year
measure: Any coronary revascularization
timeFrame: 6-year
measure: Any clinically-driven coronary revascularization
timeFrame: 6-year
measure: Coronary artery bypass grafting
timeFrame: 6-year
measure: Stroke
timeFrame: 6-year
measure: Worsening of angina due to coronary spasm
timeFrame: 6-year
measure: Bleeding complications
timeFrame: 6-year
measure: Composite of death, myocardial infarction, stroke, acute coronary syndrome, heart failure hospitalization, any coronary revascularization
timeFrame: 6-year
measure: Composite of cardiac death, myocardial infarction, acute coronary syndrome, heart failure hospitalization
timeFrame: 6-year
measure: Composite of cardiovascular death, myocardial infarction, stroke
timeFrame: 6-year
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Division of Cardiology, Kyoto University Hospital
Study officials:
affiliation: Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
name: Takeshi Kimura, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.