Myocardial InfarctionPhase 4CAPITAL-RCTNCT01155635
Carvedilol Post-intervention Long-term Administration in Large-scale Trial
A Phase 4 study testing Carvedilol and No Carvedilol in people with Myocardial Infarction, run by Takeshi Morimoto at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Carvedilol and No Carvedilol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 801 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2010to Mar 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with STEMI after primary PCI
- Patients with left ventricular ejection fraction more than or equal to 40%
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Myocardial Infarction
- Being tested
- Carvedilol, No Carvedilol
- Keywords
- Myocardial infarction, Adrenergic beta-Antagonists, Percutaneous coronary intervention
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarvedilolDrug
Use of Carvedilol with any dose
No CarvedilolDrug
No use of Carvedilol
| Study group | Role | What they receive |
|---|---|---|
| Beta-blocker | Active comparator | Use of Carvedilol with any dose Receives: Drug: Carvedilol |
| Non Beta-blocker | Active comparator | No use of Carvedilol Receives: Drug: No Carvedilol |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Death from any reason
Measured: 6-year
Composite of death, myocardial infarction, acute coronary syndrome, heart failure hospitalization
Measured: 6-year
Secondary outcomes (19)
Cardiac death
Measured: 6-year
Sudden cardiac death
Measured: 6-year
Cardiovascular death
Measured: 6-year
Myocardial infarction
Measured: 6-year
Acute coronary syndrome
Measured: 6-year
Sustained ventricular tachycardia or ventricular fibrillation
Measured: 6-year
Heart failure hospitalization
Measured: 6-year
Stent thrombosis
Stent thrombosis defined by Academic Research Consortium
Measured: 6-year
Target-vessel revascularization
Measured: 6-year
Clinically-driven target-lesion revascularization
Measured: 6-year
Any coronary revascularization
Measured: 6-year
Any clinically-driven coronary revascularization
Measured: 6-year
Coronary artery bypass grafting
Measured: 6-year
Stroke
Any ischemic and hemorrhagic strokes excluding transient ischemic attacks
Measured: 6-year
Worsening of angina due to coronary spasm
Measured: 6-year
Bleeding complications
Bleeding complications defined by GUSTO and TIMI definitions
Measured: 6-year
Composite of death, myocardial infarction, stroke, acute coronary syndrome, heart failure hospitalization, any coronary revascularization
Measured: 6-year
Composite of cardiac death, myocardial infarction, acute coronary syndrome, heart failure hospitalization
Measured: 6-year
Composite of cardiovascular death, myocardial infarction, stroke
Measured: 6-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJun 2015
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 801 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeshi Morimoto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Takeshi Morimoto, Kyoto University, Graduate School of Medicine
- Investigators
- Takeshi Kimura, MD, Principal investigator, Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01155635
- Sponsor's protocol ID
- C-417
- Acronym
- CAPITAL-RCT
- Status last verified
- Jun 2017
- First submitted
- 1 Jul 2010
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37245250Watanabe 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.
PubMed 30153268
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carvedilol Post-intervention Long-term Administration in Large-scale Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01155635
- Acronym / sponsor ID
- CAPITAL-RCT / C-417
- Conditions
- Myocardial Infarction
- Keywords
- Myocardial infarction, Adrenergic beta-Antagonists, Percutaneous coronary intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 801 participants (actual)
- Lead sponsor
- Takeshi MorimotoUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jun 2015 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 2 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beta-blocker | Active comparator | Drug: CarvedilolUse of Carvedilol with any dose |
| Non Beta-blocker | Active comparator | Drug: No CarvedilolNo use of Carvedilol |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with STEMI after primary PCI
- Patients with left ventricular ejection fraction more than or equal to 40%
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarvedilolUse of Carvedilol with any dose | Drug | Beta-blocker |
| No CarvedilolNo use of Carvedilol | Drug | Non Beta-blocker |
Primary outcome
All cause mortality
Time frame: 6-year
Death from any reason
Composite of death, myocardial infarction, acute coronary syndrome, heart failure hospitalization
Time frame: 6-year
19 secondary outcomes
Cardiac death
Time frame: 6-year
Sudden cardiac death
Time frame: 6-year
Cardiovascular death
Time frame: 6-year
Myocardial infarction
Time frame: 6-year
Acute coronary syndrome
Time frame: 6-year
Sustained ventricular tachycardia or ventricular fibrillation
Time frame: 6-year
Heart failure hospitalization
Time frame: 6-year
Stent thrombosis
Time frame: 6-year
Target-vessel revascularization
Time frame: 6-year
Clinically-driven target-lesion revascularization
Time frame: 6-year
Any coronary revascularization
Time frame: 6-year
Any clinically-driven coronary revascularization
Time frame: 6-year
Coronary artery bypass grafting
Time frame: 6-year
Stroke
Time frame: 6-year
Worsening of angina due to coronary spasm
Time frame: 6-year
Bleeding complications
Time frame: 6-year
Composite of death, myocardial infarction, stroke, acute coronary syndrome, heart failure hospitalization, any coronary revascularization
Time frame: 6-year
Composite of cardiac death, myocardial infarction, acute coronary syndrome, heart failure hospitalization
Time frame: 6-year
Composite of cardiovascular death, myocardial infarction, stroke
Time frame: 6-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
- Derived from this study: PubMed 37245250Amano 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.
- Derived from this study: PubMed 30153268Watanabe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takeshi Kimura, MD principal investigator
Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Carvedilol and No Carvedilol in people with Myocardial Infarction, run by Takeshi Morimoto at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: 6-year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01155635, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2017; AzTrials last refreshed its copy on 30 Oct 2026.