Experimental Treatment Strategy vs Reference Treatment Strategy: Number of Participants With a Bleeding Academic Research Consortium (BARC) 3 or 5 Bleeding
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 | 0.0204 | 0.0175 | 0.0238 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0212 | 0.0182 | 0.0246 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.000731 | -0.00518 | 0.00372 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.965 | 0.78 | 1.19 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.965 | 0.776 | 1.2 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on Experimental Treatment Strategy than on Reference Treatment Strategy | 1,370 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Experimental Treatment Strategy | All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.~Dosage and frequency:~Ticagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)~Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.~Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy | 163 | 7,980 | OG000 | ClinicalTrials.gov |
| Group 2 | Reference Treatment Strategy | Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.~Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.~Dosage and frequency:~Brilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd~Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.~Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy~Clopidogrel: Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for | 169 | 7,988 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants With a Bleeding Academic Research Consortium (BARC) 3 or 5 Bleeding | ClinicalTrials.gov |
| Description | BARC definition. We only considered BARC 3 or 5 for this secondary safety endpoint.~Type 3: Clinical, laboratory, and/or imaging evidence of bleeding with:~* Type 3a:~ * Overt bleeding + Hb drop of 3 to \< 5 g/dL (provided Hb drop is related to bleed)~ * Any transfusion with overt bleeding~* Type 3b:~ * Overt bleeding + Hb drop ≥5 g/dL (provided Hb drop is related to bleed)~ * Cardiac tamponade~ * Bleeding requiring surgical intervention (excluding dental/nasal/skin/haemorrhoid)~ * Bleeding requiring intravenous vasoactive agents~* Type 3c:~ * Intracranial haemorrhage (does not include microbleeds or haemorrhagic transformation, does include intraspinal)~ * Subcategories confirmed by autopsy or imaging or lumbar puncture~ * Intraocular bleed compromising vision. Type 5: Fatal bleeding~ * Type 5a:~ • Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious~ * Type 5b:~ * Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation | ClinicalTrials.gov |
| Time frame | 2 year | ClinicalTrials.gov |
| Population | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation | ClinicalTrials.gov |
| NCT number | NCT01813435 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Coronary Artery Disease (CAD) | ClinicalTrials.gov |
| Interventions | Ticagrelor, Acetylsalicylic Acid, Clopidogrel | ClinicalTrials.gov |
| Lead sponsor | ECRI bv | ClinicalTrials.gov |
| Results first posted | 2019-07-05 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT01813435?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.