Trial · NCT02145468
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With First Occurrence of Major Adverse Cardiovascular Events (MACE) Through Week 12 | Up to 12 weeks | The primary efficacy endpoint is the composite measure of adjudicated MACE that includes the time to first occurrence of CV death (death due to a cardiovascular cause), MI or SRI-UR (Severe Recurrent Ischemia requiring Urgent coronary artery Revascularization). Death for which the Clinical Events Committee (CEC) or investigator were unable to establish cause were analyzed as CV deaths. |
| Secondary | Number of Participants With First Occurrence of MACE Through Week 24 | Up to Week 24 | Number of participants with first occurrence of MACE through Week 24 including CV death, MI or SRI-UR are presented. Death for which the CEC or investigator were unable to establish cause were analyzed as CV deaths. |
| Secondary | Number of Participants With First Occurrence of the Composite of CV Death or MI up to Week 12 and Week 24 | Week 12 and Week 24 | Week 12 results are considered the principal secondary endpoint. Number of participants with first occurrence of the composite of CV death or MI up to Week 12 and Week 24 are summarized. |
| Secondary | Number of Participants With First Occurrence of the Composite of CV Death, MI or Hospitalization for Heart Failure (HF) up to Week 12 and Week 24. | Week 12 and Week 24 | Number of participants with first occurrence of the composite of CV death, MI or hospitalization for HF up to Week 12 and Week 24 are presented. |
| Secondary | Number of Participants With First Occurrence of the Expanded Composite of Arterial CV Events Defined as CV Death, MI, SRI-UR or Stroke Through to Week 12 and Week 24 | Week 12, Week 24 | Number of participants with first occurrence of the expanded composite of arterial CV events defined as CV death, MI, SRI-UR or stroke through to Week 12 and Week 24 are presented. |
| Secondary | Number of Participants With First Occurrence of the Composite of Coronary Events Defined as CHD Death, MI, SRI-UR or Any Unplanned Coronary Artery Revascularization Through to Week 12 and Week 24 | Week 12, Week 24 | Number of participants with first occurrence of the composite of coronary events defined as coronary heart disease (CHD) death, MI, SRI-UR or any unplanned coronary artery revascularization through to Week 12 and Week 24 are presented. |
| Secondary | Number of Participants With First Occurrence of the Composite of CV Death or Hospitalization for HF Through to Week 12 and Week 24 | Week 12, Week 24 | Number of participants with first occurrence of the composite of CV death or hospitalization for HF through to Week 12 and Week 24 are presented. |
| Secondary | Number of Participants With First Occurrence of the Composite of CV Death, MI or Stroke Through to Week 12 and Week 24 | Week 12, Week 24 | Number of participants with first occurrence of the composite of CV death, MI or stroke through to Week 12 and Week 24 are presented. |
| Secondary | Number of Participants With First Occurrence of the Expanded Composite of CV Death, MI, SRI-UR, Stroke or Hospitalization for HF Through to Week 12 and Week 24 | Week 12, Week 24 | Number of participants with first occurrence of the expanded composite of CV death, MI, SRI-UR, stroke or hospitalization for HF through to Week 12 and Week 24 are presented. |
| Secondary | Number of Participants With First Occurrence of the Composite of CHD Death, MI or SRI-UR Through to Week 12 and Week 24 | Week 12, Week 24 | Number of participants with first occurrence of the composite of CHD death, MI or SRI-UR through to Week 12 and Week 24 are presented. |
| Secondary | Number of Participants With First Occurrence of the Composite of CHD Death or MI Through to Week 12 and Week 24 | Week 12, Week 24 | Number of participants with first occurrence of the composite of CHD death or MI through to Week 12 and Week 24 are presented. |
| Secondary | Number of Participants With First Occurrence of the Composite of All-cause Death, MI or SRI-UR Through to Week 12 and Week 24 | Week 12, Week 24 | Number of participants with first occurrence of the composite of all-cause death, MI or SRI-UR through to Week 12 and Week 24 are presented. |
| Secondary | Number of Participants With First Occurrence of the Composite of All-cause Death or MI Through to Week 12 and Week 24 | Week 12, Week 24 | Number of participants with first occurrence of the composite of all-cause death or MI through to Week 12 and Week 24 are presented. |
| Secondary | Number of Participants With First Occurrence of the Composite of CV Death, Type I (Spontaneous) MI or SRI-UR Through to Week 12 and Week 24 | Week 12, Week 24 | Number of participants with first occurrence of the composite of CV death, type I (spontaneous) MI or SRI-UR through to Week 12 and Week 24 are presented. |
| Secondary | Number of Participants With First Occurrence of the Composite of CV Death or Type I (Spontaneous) MI Through to Week 12 and Week 24 | Week 12, Week 24 | Number of participants with first occurrence of the composite of CV death or type I (spontaneous) MI through to Week 12 and Week 24 are presented. |
| Secondary | Number of Participants With First Occurrence of Definite or Probable Stent Thrombosis Through to Week 12 and Week 24 | Week 12, Week 24 | Number of participants with first occurrence of definite or probable stent thrombosis through to Week 12 and Week 24 are presented. Participants receiving stent prior to randomization or during the study prior to Week 12 were included. |
| Secondary | Number of Participants Re-hospitalized Within 30 Days of Discharge | Within up to 30 days of post discharge | Participants who had a death or re-hospitalization within 30 days of discharge, plus participants who were never discharged from the initial hospitalization were included. |
| Secondary | Number of Participants With All-cause Mortality Through to Week 12 and Week 24 | Week 12, Week 24 | Number of participants with all-cause mortality through to Week 12 and Week 24 are presented. |
| Secondary | Number of Participants With CV Death Events Through to Week 12 and Week 24 | Week 12, Week 24 | Number of participants with CV death events through to Week 12 and Week 24 are presented. |
| Secondary | Number of Participants With CHD Death Events Through to Week 12 and Week 24 | Week 12, Week 24 | Number of participants with CHD death events through to Week 12 and Week 24 are presented. |
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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