Trial · NCT01994720
[SOCRATES -Acute Stroke Or Transient IsChaemic Attack TReated With Aspirin or Ticagrelor and Patient OutcomES]
NCT01994720, Phase 3, Completed, AstraZeneca; results first posted 2017-06-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. [SOCRATES -Acute Stroke Or Transient IsChaemic Attack TReated With Aspirin or Ticagrelor and Patient OutcomES]. Trials, record NCT01994720. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01994720
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- [SOCRATES -Acute Stroke Or Transient IsChaemic Attack TReated With Aspirin or Ticagrelor and Patient OutcomES]
- NCT number
- NCT01994720
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 13,307 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Acute Ischaemic Stroke, Transient Ischaemic Attack
- Interventions
- ticagrelor, Acetylsalicylic acid (ASA)
- First posted
- 2013-11-26
- Last updated
- 2017-06-12
- Other registries' IDs
- eudract:2012-003895-38
- Results first posted
- 2017-06-12
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Composite of Stroke/MI/Death | From randomization up to 97 days | Participants with stroke, MI or death. If no event, censoring occures at the minimum of (last date of event assessment, end of treatment date, day 97). |
| Secondary | Number of Participants With Ischaemic Stroke | From randomization up to 97 days | Participants with ischaemic stroke. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97). |
| Secondary | Net Clinical Outcome | From randomization up to 97 days | Participants with stroke, MI, death or life-threatening bleeding. If no event, censoring occures at the minimum of (last date of event assessment, end of treatment date, day 97). |
| Secondary | Number of Participants With Composite of Ischaemic Stroke, MI and CV Death | From randomization up to 97 days | Participants with ischaemic stroke, MI or CV death. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97). |
| Secondary | Number of Participants With All-Cause Death | From randomization up to 97 days | Participants with all-cause death. If no event, censoring at the minimum of (last date of event assessment, end of treatment date, day 97). |
| Secondary | Number of Participants With CV Death | From randomization up to 97 days | Participants with CV death. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97). |
| Secondary | Number of Participants With MI | From randomization up to 97 days | Participants with MI. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97) |
| Secondary | Number of Participants by Severity of Stroke and Overall Disability | From randomization up to 97 days | Analysis of severity of stroke and overall disability of patients, using the modified Rankin Score, mRS. Modified Rankin Score: 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead. Disability defined as mRS \> 1. Odds ratio and p-value are calculated for ticagrelor versus ASA from a logistic regression model with treatment group, history of stroke and NIHSS (National Institutes of Health Stroke Scale) at baseline as explanatory variables. |
| Secondary | Number of Participants With Stroke | From randomization up to 97 days | Participants with stroke. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97) |
| Secondary | Number of Participants With Fatal Stroke | From randomization up to 97 days | Participants with fatal stroke. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97). |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
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 Composite of Stroke/MI/Death | From randomization up to 97 days | The population was the full analysis set, which included all randomized patients. | Participants | NUMBER |
| SECONDARY | Number of Participants With Ischaemic Stroke | From randomization up to 97 days | The population was the full analysis set, which included all randomized patients. | Participants | NUMBER |
| SECONDARY | Net Clinical Outcome | From randomization up to 97 days | The population was the full analysis set, which included all randomized patients. | Participants | NUMBER |
| SECONDARY | Number of Participants With Composite of Ischaemic Stroke, MI and CV Death | From randomization up to 97 days | The population was the full analysis set, which included all randomized patients. | Participants | NUMBER |
| SECONDARY | Number of Participants With All-Cause Death | From randomization up to 97 days | The population was the full analysis set, which included all randomized patients. | Participants | NUMBER |
| SECONDARY | Number of Participants With CV Death | From randomization up to 97 days | The population was the full analysis set, which included all randomized patients. | Participants | NUMBER |
| SECONDARY | Number of Participants With MI | From randomization up to 97 days | The population was the full analysis set, which included all randomized patients. | Participants | NUMBER |
| SECONDARY | Number of Participants by Severity of Stroke and Overall Disability | From randomization up to 97 days | The population was the full analysis set which included all randomized patients. | Participants | NUMBER |
| SECONDARY | Number of Participants With Stroke | From randomization up to 97 days | The population was the full analysis set, which included all randomized patients. | Participants | NUMBER |
| SECONDARY | Number of Participants With Fatal Stroke | From randomization up to 97 days | The population was the full analysis set, which included all randomized patients. | Participants | NUMBER |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group60
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 Composite of Stroke/MI/Death | Ticagrelor 90 mg | 442 | Participants | ||
| Number of Participants With Composite of Stroke/MI/Death | ASA 100 mg | 497 | Participants | ||
| Number of Participants With Ischaemic Stroke | Ticagrelor 90 mg | 385 | Participants | ||
| Number of Participants With Ischaemic Stroke | ASA 100 mg | 441 | Participants | ||
| Net Clinical Outcome | Ticagrelor 90 mg | 457 | Participants | ||
| Net Clinical Outcome | ASA 100 mg | 508 | Participants | ||
| Number of Participants With Composite of Ischaemic Stroke, MI and CV Death | Ticagrelor 90 mg | 423 | Participants | ||
| Number of Participants With Composite of Ischaemic Stroke, MI and CV Death | ASA 100 mg | 475 | Participants | ||
| Number of Participants With All-Cause Death | Ticagrelor 90 mg | 68 | Participants | ||
| Number of Participants With All-Cause Death | ASA 100 mg | 58 | Participants |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ticagrelor 90 mg | 6,589 | |
| Overall Study | STARTED | ASA 100 mg | 6,610 | |
| Overall Study | COMPLETED | Ticagrelor 90 mg | 6,543 | |
| Overall Study | COMPLETED | ASA 100 mg | 6,554 | |
| Overall Study | NOT COMPLETED | Ticagrelor 90 mg | 46 | |
| Overall Study | NOT COMPLETED | ASA 100 mg | 56 |
Source ClinicalTrials.gov
Adverse events900
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 |
|---|---|---|---|---|---|---|
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | ASA 100mg | 85 | 6,581 | 86 |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Ticagrelor 90mg | 383 | 6,549 | 425 |
| serious | Anaemia | Blood and lymphatic system disorders | ASA 100mg | 2 | 6,581 | 2 |
| serious | Anaemia | Blood and lymphatic system disorders | Ticagrelor 90mg | 0 | 6,549 | 0 |
| serious | Antiphospholipid syndrome | Blood and lymphatic system disorders | ASA 100mg | 1 | 6,581 | 1 |
| serious | Antiphospholipid syndrome | Blood and lymphatic system disorders | Ticagrelor 90mg | 0 | 6,549 | 0 |
| serious | Hypochromic anaemia | Blood and lymphatic system disorders | ASA 100mg | 0 | 6,581 | 0 |
| serious | Hypochromic anaemia | Blood and lymphatic system disorders | Ticagrelor 90mg | 1 | 6,549 | 1 |
| serious | Iron deficiency anaemia | Blood and lymphatic system disorders | ASA 100mg | 0 | 6,581 | 0 |
| serious | Iron deficiency anaemia | Blood and lymphatic system disorders | Ticagrelor 90mg | 1 | 6,549 | 1 |
1 to 10 of 900Source ClinicalTrials.gov
See all 900 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ASA 100mg | ||
| Total, all-cause mortality | Ticagrelor 90mg | ||
| Total, other adverse events | ASA 100mg | 85 | 6,581 |
| Total, other adverse events | Ticagrelor 90mg | 383 | 6,549 |
| Total, serious adverse events | ASA 100mg | 533 | 6,581 |
| Total, serious adverse events | Ticagrelor 90mg | 532 | 6,549 |
Source ClinicalTrials.gov
Papers12
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 comparisons14
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ticagrelor 90 mg vs ASA 100 mg: Number of Participants With Composite of Stroke/MI/Death | Trial comparisons |
| Ticagrelor 90 mg vs ASA 100 mg: Number of Participants With Ischaemic Stroke | Trial comparisons |
| Ticagrelor 90 mg vs ASA 100 mg: Number of Participants With Premature Discontinuation of Study Drug Due to Any Bleeding Adverse Event | Trial comparisons |
| Ticagrelor 90 mg vs ASA 100 mg: Number of Participants With CV Death | Trial comparisons |
| Ticagrelor 90 mg vs ASA 100 mg: Number of Participants With All-Cause Death | Trial comparisons |
| Ticagrelor 90 mg vs ASA 100 mg: Number of Participants With PLATO Major Bleeding Event | Trial comparisons |
| Ticagrelor 90 mg vs ASA 100 mg: Number of Participants With Fatal Stroke | Trial comparisons |
| Ticagrelor 90 mg vs ASA 100 mg: Number of Participants With Composite of Ischaemic Stroke, MI and CV Death | Trial comparisons |
| Ticagrelor 90 mg vs ASA 100 mg: Number of Participants by Severity of Stroke and Overall Disability | Trial comparisons |
| Ticagrelor 90 mg vs ASA 100 mg: Number of Participants With Stroke | Trial comparisons |
1 to 10 of 14
See all 14 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/NCT01994720
GET https://conductscience.org/api/trials/v1/NCT01994720/results?page=2