Trial · NCT07577518
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants with Patient-oriented composite outcome (POCO), defined as the composite of cardiovascular death, non-fatal myocardial infarction (MI), or clinically driven revascularization | 2nd year and 5th year since registration was complete | This outcome applies to the main RCT (n=2,301). POCO is a composite of three components: (1) cardiovascular death; (2) non-fatal myocardial infarction, excluding periprocedural MI; and (3) clinically driven revascularization. The first occurrence of any component is counted as the primary event per participant. Clinically driven revascularization is defined as revascularization of a coronary segment with diameter stenosis ≥50% by quantitative coronary angiography, accompanied by at least one of the following: ischemic ECG(Electrocardiogram) changes at rest; typical ischemic symptoms refractory to medical therapy; unstable angina; positive invasive physiologic test (FFR(Fractional Flow Reserve) ≤0.80 or iFR (Instantaneous Wave-Free Ratio) ≤0.89); or angiographic progression with diameter stenosis ≥70% by quantitative coronary angiography regardless of other criteria. |
| Primary | Change in Seattle Angina Questionnaire-7 (SAQ-7) Summary Score from Baseline to 12 Months (for Nested RCT) | One year after registration | This outcome applies to the Nested RCT substudy only (n=220), in which participants eligible for beta-blocker therapy are independently randomized 1:1 to carvedilol SR or IR, regardless of their main trial allocation. The SAQ-7 is a 7-item validated questionnaire assessing angina-related health status across three domains: physical limitation, angina frequency, and quality of life. Scores range from 0 to 100, with higher scores indicating fewer symptoms and better quality of life. The SAQ-7 Summary score is calculated as the mean of the three domain scores. |
| Secondary | Number of Participants with All-cause death | 2nd year and 5th year since registration was complete | |
| Secondary | Number of Participants with Cardiovascular death | 2nd year and 5th year since registration was complete | |
| Secondary | Number of Participants with Cardiovascular Death or Non-Fatal Myocardial Infarction | 2nd year and 5th year since registration was complete | |
| Secondary | Number of Participants with Myocardial Infarction | 2nd year and 5th year since registration was complete | |
| Secondary | Number of Participants with Spontaneous myocardial infarction | 2nd year and 5th year since registration was complete | |
| Secondary | Number of Participants with Periprocedural myocardial infarction | 2nd year and 5th year since registration was complete | |
| Secondary | Number of Participants with Periprocedural myocardial infarction, as defined by the Fourth Universal Definition of Myocardial Infarction | 2nd year and 5th year since registration was complete | |
| Secondary | Number of Participants with Ischemic stroke | 2nd year and 5th year since registration was complete | |
| Secondary | Number of Participants with Stent thrombosis | 2nd year and 5th year since registration was complete | |
| Secondary | Number of Participants with Transient ischemic attack | 2nd year and 5th year since registration was complete | |
| Secondary | Number of Participants with Clinically driven revascularization | 2nd year and 5th year since registration was complete | |
| Secondary | Number of Participants with any revascularization | 2nd year and 5th year since registration was complete | |
| Secondary | Number of Participants with ischemia driven revascularization | 2nd year and 5th year since registration was complete | |
| Secondary | Number of Participants with Major bleeding events | 2nd year and 5th year since registration was complete | BARC(Bleeding Academic Research Consortium) classification, type 3 or 5 |
| Secondary | Number of Participants with Clinically relevant non-major bleeding events | 2nd year and 5th year since registration was complete | BARC(Bleeding Academic Research Consortium) classification, type 2 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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