Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beta-blocker | Active Comparator | Use of Carvedilol with any dose |
|
| Non Beta-blocker | Active Comparator | No use of Carvedilol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carvedilol | Drug | Use of Carvedilol with any dose |
| |
| No Carvedilol |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac death | 6-year | |
| Sudden cardiac death | 6-year | |
| Cardiovascular death |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Takeshi Kimura, MD | Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology, Kyoto University Hospital | Kyoto | 606-8507 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37245250 | Derived | 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. | |
| 30153268 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077261 | Carvedilol |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
No use of Carvedilol |
|
| 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 |
| Derived |
| 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. |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D020005 |
| Propanols |
| D000588 | Amines |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |