Darapladib 160 mg vs Placebo: Number of Participants With First Occurrence of Any Event in the Composite of Total Coronary Events (CHD Death, Non-fatal MI, Hospitalization for Unstable Angina, or Any Coronary Revascularization Procedure) During the Time Period for FU of CV Events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.198 | 0.189 | 0.208 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.207 | 0.198 | 0.217 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.00896 | -0.0228 | 0.00485 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.957 | 0.894 | 1.02 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.946 | 0.869 | 1.03 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on Darapladib 160 mg than on Placebo | 112 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Darapladib 160 mg | Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily. | 1,290 | 6,504 | OG001 | ClinicalTrials.gov |
| Group 2 | Placebo | Participants were randomized to receive matching placebo once daily. | 1,352 | 6,522 | OG000 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants With First Occurrence of Any Event in the Composite of Total Coronary Events (CHD Death, Non-fatal MI, Hospitalization for Unstable Angina, or Any Coronary Revascularization Procedure) During the Time Period for FU of CV Events | ClinicalTrials.gov |
| Description | CHD death, acute MI, and prior MI diagnosed post-randomization are defined in the primary endpoint (major coronary events). Hospitalization for unstable angina=one of the following, but not fulfilling the criteria for MI: ischemic discomfort at rest associated with electrocardiogram (ECG) changes leading to hospitalization; ischemic discomfort at rest regardless of ECG changes leading to hospitalization and revascularization during the same admission; ischemic discomfort at rest in hospital associated with ECG changes; ischemic discomfort at rest in hospital without ECG changes resulting in revascularization during the same admission. NOTE: The event was not considered to be unstable angina if, after invasive/non-invasive testing or other diagnostic testing, the discomfort was found not to be caused by myocardial ischemia. Coronary revascularization procedures exclude PCI planned prior to randomization but performed after randomization. | ClinicalTrials.gov |
| Time frame | From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years) | ClinicalTrials.gov |
| Population | All-Randomized ITT Population | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | The Stabilization Of pLaques usIng Darapladib-Thrombolysis In Myocardial Infarction 52 Trial | ClinicalTrials.gov |
| NCT number | NCT01000727 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Acute Coronary Syndrome | ClinicalTrials.gov |
| Interventions | Darapladib 160 mg, Placebo, Standard Therapy | ClinicalTrials.gov |
| Lead sponsor | GlaxoSmithKline | ClinicalTrials.gov |
| Results first posted | 2017-08-10 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT01000727?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| Tables read | outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.