Trial · NCT01813435
GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation
NCT01813435, Phase 3, Completed, ECRI bv; results first posted 2019-07-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation. Trials, record NCT01813435. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01813435
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation
- NCT number
- NCT01813435
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 15,991 participants, actual
- Lead sponsor
- ECRI bv
- Conditions
- Coronary Artery Disease (CAD)
- Interventions
- Ticagrelor, Acetylsalicylic Acid, Clopidogrel
- First posted
- 2013-03-19
- Last updated
- 2022-03-15
- Results first posted
- 2019-07-05
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Composite of All-cause Mortality or Non-fatal New Q-wave Myocardial Infarction (MI) | 2 year | Number of Participants with a composite of all-cause mortality or non-fatal new Q-wave MI up to 2 years post randomisation. |
| Secondary | Number of Participants With All-cause Mortality | 2-year | |
| Secondary | Number of Participants With Myocardial Infarction | 2 year | |
| Secondary | Number of Participants With New Q-wave Myocardial Infarction | 2-year | |
| Secondary | Number of Participants With a Composite of All-cause Mortality, Stroke, or New Q-wave Myocardial Infarction | 2-year | shown are the first event per event type for each patient only. Multiple events of the same type within the same patient are disregarded |
| Secondary | Number of Participants With a Stroke | 2 year | |
| Secondary | Number of Participants With a Myocardial Revascularisation | 2 year | |
| Secondary | Number of Participants With a Definite Stent Thrombosis | 2 year | |
| Secondary | Number of Participants With a Bleeding Academic Research Consortium (BARC) 3 or 5 Bleeding | 2 year | 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 |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Composite of All-cause Mortality or Non-fatal New Q-wave Myocardial Infarction (MI) | 2 year | Shown are the first event per event type for each patient only. Multiple events of the same type within the same patient are disregarded. Data were censored 730 days after index percutaneous coronary intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With All-cause Mortality | 2-year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Myocardial Infarction | 2 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With New Q-wave Myocardial Infarction | 2-year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With a Composite of All-cause Mortality, Stroke, or New Q-wave Myocardial Infarction | 2-year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With a Stroke | 2 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With a Myocardial Revascularisation | 2 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With a Definite Stent Thrombosis | 2 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With a Bleeding Academic Research Consortium (BARC) 3 or 5 Bleeding | 2 year | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Composite of All-cause Mortality or Non-fatal New Q-wave Myocardial Infarction (MI) | Experimental Treatment Strategy | 304 | Participants | ||
| Number of Participants With a Composite of All-cause Mortality or Non-fatal New Q-wave Myocardial Infarction (MI) | Reference Treatment Strategy | 349 | Participants | ||
| Number of Participants With All-cause Mortality | Experimental Treatment Strategy | 224 | Participants | ||
| Number of Participants With All-cause Mortality | Reference Treatment Strategy | 253 | Participants | ||
| Number of Participants With Myocardial Infarction | Experimental Treatment Strategy | 248 | Participants | ||
| Number of Participants With Myocardial Infarction | Reference Treatment Strategy | 250 | Participants | ||
| Number of Participants With New Q-wave Myocardial Infarction | Experimental Treatment Strategy | 83 | Participants | ||
| Number of Participants With New Q-wave Myocardial Infarction | Reference Treatment Strategy | 103 | Participants | ||
| Number of Participants With a Composite of All-cause Mortality, Stroke, or New Q-wave Myocardial Infarction | Experimental Treatment Strategy | 362 | Participants | ||
| Number of Participants With a Composite of All-cause Mortality, Stroke, or New Q-wave Myocardial Infarction | Reference Treatment Strategy | 416 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Experimental Treatment Strategy | 7,980 | |
| Overall Study | STARTED | Reference Treatment Strategy | 7,988 | |
| Overall Study | COMPLETED | Experimental Treatment Strategy | 5,810 | |
| Overall Study | COMPLETED | Reference Treatment Strategy | 6,981 | |
| Overall Study | NOT COMPLETED | Experimental Treatment Strategy | 2,170 | |
| Overall Study | NOT COMPLETED | Reference Treatment Strategy | 1,007 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | new Q-wave MI | Cardiac disorders | Experimental Treatment Strategy | 83 | 7,980 | |
| serious | new Q-wave MI | Cardiac disorders | Reference Treatment Strategy | 103 | 7,988 | |
| serious | MI | Cardiac disorders | Experimental Treatment Strategy | 248 | 7,980 | |
| serious | MI | Cardiac disorders | Reference Treatment Strategy | 250 | 7,988 | |
| serious | stroke | Vascular disorders | Experimental Treatment Strategy | 162 | 7,980 | |
| serious | stroke | Vascular disorders | Reference Treatment Strategy | 164 | 7,988 | |
| serious | revascularisation | Vascular disorders | Experimental Treatment Strategy | 739 | 7,980 | |
| serious | revascularisation | Vascular disorders | Reference Treatment Strategy | 793 | 7,988 | |
| serious | definite stent thrombosis | Vascular disorders | Experimental Treatment Strategy | 64 | 7,980 | |
| serious | definite stent thrombosis | Vascular disorders | Reference Treatment Strategy | 64 | 7,988 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Experimental Treatment Strategy | 224 | 7,980 |
| Total, all-cause mortality | Reference Treatment Strategy | 253 | 7,988 |
| Total, other adverse events | Experimental Treatment Strategy | 0 | 7,980 |
| Total, other adverse events | Reference Treatment Strategy | 0 | 7,988 |
| Total, serious adverse events | Experimental Treatment Strategy | 1,459 | 7,980 |
| Total, serious adverse events | Reference Treatment Strategy | 1,543 | 7,988 |
Source ClinicalTrials.gov
Papers20
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons11
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Experimental Treatment Strategy vs Reference Treatment Strategy: Number of Participants With a Composite of All-cause Mortality or Non-fatal New Q-wave Myocardial Infarction (MI) | Trial comparisons |
| Experimental Treatment Strategy vs Reference Treatment Strategy: Number of Participants With All-cause Mortality | Trial comparisons |
| Experimental Treatment Strategy vs Reference Treatment Strategy: Number of Participants With Myocardial Infarction | Trial comparisons |
| Experimental Treatment Strategy vs Reference Treatment Strategy: Number of Participants With a Myocardial Revascularisation | Trial comparisons |
| Experimental Treatment Strategy vs Reference Treatment Strategy: Number of Participants With New Q-wave Myocardial Infarction | Trial comparisons |
| Experimental Treatment Strategy vs Reference Treatment Strategy: Number of Participants With a Bleeding Academic Research Consortium (BARC) 3 or 5 Bleeding | Trial comparisons |
| Experimental Treatment Strategy vs Reference Treatment Strategy: Number of Participants With a Definite Stent Thrombosis | Trial comparisons |
| Experimental Treatment Strategy vs Reference Treatment Strategy: deaths from any cause | Trial comparisons |
| Experimental Treatment Strategy vs Reference Treatment Strategy: Number of Participants With a Composite of All-cause Mortality, Stroke, or New Q-wave Myocardial Infarction | Trial comparisons |
| Experimental Treatment Strategy vs Reference Treatment Strategy: Number of Participants With a Stroke | Trial comparisons |
1 to 10 of 11
See all 11 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01813435
GET https://conductscience.org/api/trials/v1/NCT01813435/registered