NCT01155635

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
801

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2010

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

June 27, 2017

Status Verified

June 1, 2017

Enrollment Period

4.9 years

First QC Date

July 1, 2010

Last Update Submit

June 25, 2017

Conditions

Myocardial Infarction

Keywords

Myocardial infarctionAdrenergic beta-AntagonistsPercutaneous coronary intervention

Outcome Measures

Primary Outcomes (2)

  • All cause mortality

    Death from any reason

    6-year

  • Composite of death, myocardial infarction, acute coronary syndrome, heart failure hospitalization

    6-year

Secondary Outcomes (19)

  • Cardiac death

    6-year

  • Sudden cardiac death

    6-year

  • Cardiovascular death

    6-year

  • Myocardial infarction

    6-year

  • Acute coronary syndrome

    6-year

  • +14 more secondary outcomes

Study Arms (2)

Beta-blocker

ACTIVE COMPARATOR

Use of Carvedilol with any dose

Drug: Carvedilol

Non Beta-blocker

ACTIVE COMPARATOR

No use of Carvedilol

Drug: No Carvedilol

Interventions

CarvedilolDRUG

Use of Carvedilol with any dose

Beta-blocker
No CarvedilolDRUG

No use of Carvedilol

Non Beta-blocker

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with STEMI after primary PCI
  • Patients with left ventricular ejection fraction more than or equal to 40%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

Related Publications (2)

  • Amano M, Izumi C, Watanabe H, Ozasa N, Morimoto T, Bingyuan B, Suwa S, Miyake M, Tamura T, Nakagawa Y, Kadota K, Inuzuka Y, Minamimoto Y, Furukawa Y, Kaji S, Suzuki T, Akao M, Inada T, Kimura T; CAPITAL-RCT Investigators. Effects of Long-Term Carvedilol Therapy in Patients With ST-Segment Elevation Myocardial Infarction and Mildly Reduced Left Ventricular Ejection Fraction. Am J Cardiol. 2023 Jul 15;199:50-58. doi: 10.1016/j.amjcard.2023.04.042. Epub 2023 May 26.

    PMID: 37245250DERIVED

  • 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.

    PMID: 30153268DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-Ring

Study Officials

  • Takeshi Kimura, MD

    Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 1, 2010

First Posted

July 2, 2010

Study Start

July 1, 2010

Primary Completion

June 1, 2015

Study Completion

March 1, 2017

Last Updated

June 27, 2017

Record last verified: 2017-06

Locations

JP(1)