Trial · NCT00153062
PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes
NCT00153062, Phase 4, Completed, Boehringer Ingelheim; results first posted 2009-09-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes. Trials, record NCT00153062. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00153062
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes
- NCT number
- NCT00153062
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 20,332 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Stroke
- Interventions
- Aggrenox, Aggrenox, Clopidogrel placebo, Clopidogrel placebo, Micardis, Micardis, Aggrenox placebo, Aggrenox placebo, Clopidogrel, Clopidogrel, Micardis placebo, Micardis placebo
- First posted
- 2005-09-12
- Last updated
- 2014-05-13
- Results first posted
- 2009-09-02
- Limitations and caveats
All SAEs and AEs that led to temporary or permanent trial drug discontinuation were reported, except in Japan, where all AEs were collected. Protocol-defined outcome events were not reported as AEs, but were recorded on the appropriate form
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only) | time since randomization; follow-up period is 1.5 to 4.4 years | |
| Primary | Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only) | time since randomization; follow-up period is 1.5 to 4.4 years | |
| Secondary | Composite Outcome of Stroke, Myocardial Infarction (MI), or Vascular Death (Antiplatelet Comparison Only) | time since randomization; follow-up period is 1.5 to 4.4 years | Number of patients with any of stroke, myocardial infarction, vascular death |
| Secondary | Composite Outcome of Stroke, Myocardial Infarction, Vascular Death, or New or Worsening Congestive Heart Failure (CHF) (Telmisartan vs. Placebo Only) | time since randomization; follow-up period is 1.5 to 4.4 years | Number of patients with any of stroke, myocardial infarction, vascular death, or new or worsening congestive heart failure |
| Secondary | Number of Patients With New Onset of Diabetes (Telmisartan vs. Placebo Only) | Randomization to final patient contact |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only) | time since randomization; follow-up period is 1.5 to 4.4 years | Patients were analyzed as randomized and were included in the analysis until final patient contact regardless of whether they were still on treatment. | Participants | NUMBER |
| SECONDARY | Composite Outcome of Stroke, Myocardial Infarction (MI), or Vascular Death (Antiplatelet Comparison Only) | time since randomization; follow-up period is 1.5 to 4.4 years | Patients were analyzed as randomized and were included in the analysis until final patient contact regardless of whether they were still on treatment. | Participants | NUMBER |
| SECONDARY | Composite Outcome of Stroke, Myocardial Infarction, Vascular Death, or New or Worsening Congestive Heart Failure (CHF) (Telmisartan vs. Placebo Only) | time since randomization; follow-up period is 1.5 to 4.4 years | Patients were analyzed as randomized and were included in the analysis until final patient contact regardless of whether they were still on treatment. | Participants | NUMBER |
| SECONDARY | Number of Patients With New Onset of Diabetes (Telmisartan vs. Placebo Only) | Randomization to final patient contact | Patients who did not have diabetes mellitus at baseline were analyzed as randomized and were included in the analysis until final patient contact regardless of whether they were still on treatment. | Participants | NUMBER |
| PRIMARY | Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only) | time since randomization; follow-up period is 1.5 to 4.4 years | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only) | Aspirin + Extended Release Dipyridamole | 916 | Participants | ||
| Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only) | Clopidogrel | 898 | Participants | ||
| Composite Outcome of Stroke, Myocardial Infarction (MI), or Vascular Death (Antiplatelet Comparison Only) | Aspirin + Extended Release Dipyridamole | 1333 | Participants | ||
| Composite Outcome of Stroke, Myocardial Infarction (MI), or Vascular Death (Antiplatelet Comparison Only) | Clopidogrel | 1333 | Participants | ||
| Composite Outcome of Stroke, Myocardial Infarction, Vascular Death, or New or Worsening Congestive Heart Failure (CHF) (Telmisartan vs. Placebo Only) | Telmisartan | 1367 | Participants | ||
| Composite Outcome of Stroke, Myocardial Infarction, Vascular Death, or New or Worsening Congestive Heart Failure (CHF) (Telmisartan vs. Placebo Only) | Placebo | 1463 | Participants | ||
| Number of Patients With New Onset of Diabetes (Telmisartan vs. Placebo Only) | Telmisartan | 125 | Participants | ||
| Number of Patients With New Onset of Diabetes (Telmisartan vs. Placebo Only) | Placebo | 151 | Participants | ||
| Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only) | Telmisartan | 880 | Participants | ||
| Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only) | Placebo | 934 | Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aspirin + Extended Release Dipyridamole / Telmisartan | 5,086 | |
| Overall Study | STARTED | Aspirin + Extended Release Dipyridamole / Placebo | 5,095 | |
| Overall Study | STARTED | Clopidogrel / Telmisartan | 5,060 | |
| Overall Study | STARTED | Clopidogrel / Placebo | 5,091 | |
| Overall Study | COMPLETED | Aspirin + Extended Release Dipyridamole / Telmisartan | 4,699 | |
| Overall Study | COMPLETED | Aspirin + Extended Release Dipyridamole / Placebo | 4,689 | |
| Overall Study | COMPLETED | Clopidogrel / Telmisartan | 4,645 | |
| Overall Study | COMPLETED | Clopidogrel / Placebo | 4,680 | |
| Overall Study | NOT COMPLETED | Aspirin + Extended Release Dipyridamole / Telmisartan | 387 | |
| Overall Study | NOT COMPLETED | Aspirin + Extended Release Dipyridamole / Placebo | 406 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events5,596
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 | Headache (leading to permanent discont. of study medication) | Nervous system disorders | Aspirin + Extended Release Dipyridamole / Telmisartan | 318 | 5,013 | |
| other | Headache (leading to permanent discont. of study medication) | Nervous system disorders | Aspirin + Extended Release Dipyridamole / Placebo | 280 | 5,024 | |
| other | Headache (leading to permanent discont. of study medication) | Nervous system disorders | Clopidogrel / Telmisartan | 42 | 5,000 | |
| other | Headache (leading to permanent discont. of study medication) | Nervous system disorders | Clopidogrel / Placebo | 50 | 5,023 | |
| other | Dizziness or lightheadedness (Solicited question at Day 7) | Nervous system disorders | Aspirin + Extended Release Dipyridamole / Telmisartan | 768 | 5,086 | |
| other | Dizziness or lightheadedness (Solicited question at Day 7) | Nervous system disorders | Aspirin + Extended Release Dipyridamole / Placebo | 597 | 5,095 | |
| other | Dizziness or lightheadedness (Solicited question at Day 7) | Nervous system disorders | Clopidogrel / Telmisartan | 510 | 5,060 | |
| other | Dizziness or lightheadedness (Solicited question at Day 7) | Nervous system disorders | Clopidogrel / Placebo | 398 | 5,091 | |
| other | Headache (Solicited question at Day 7) | Nervous system disorders | Aspirin + Extended Release Dipyridamole / Telmisartan | 1,515 | 5,086 | |
| other | Headache (Solicited question at Day 7) | Nervous system disorders | Aspirin + Extended Release Dipyridamole / Placebo | 1,556 | 5,095 |
1 to 10 of 5,596Source ClinicalTrials.gov
See all 5,596 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aspirin + Extended Release Dipyridamole / Telmisartan | ||
| Total, all-cause mortality | Aspirin + Extended Release Dipyridamole / Placebo | ||
| Total, all-cause mortality | Clopidogrel / Telmisartan | ||
| Total, all-cause mortality | Clopidogrel / Placebo | ||
| Total, other adverse events | Aspirin + Extended Release Dipyridamole / Telmisartan | 1,856 | |
| Total, other adverse events | Aspirin + Extended Release Dipyridamole / Placebo | 1,810 | |
| Total, other adverse events | Clopidogrel / Telmisartan | 866 | |
| Total, other adverse events | Clopidogrel / Placebo | 810 | |
| Total, serious adverse events | Aspirin + Extended Release Dipyridamole / Telmisartan | 1,145 | |
| Total, serious adverse events | Aspirin + Extended Release Dipyridamole / Placebo | 1,124 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers8
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Telmisartan vs Placebo: Number of Patients With New Onset of Diabetes (Telmisartan vs. Placebo Only) | Trial comparisons |
| Telmisartan vs Placebo: Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only) | Trial comparisons |
| Telmisartan vs Placebo: Composite Outcome of Stroke, Myocardial Infarction, Vascular Death, or New or Worsening Congestive Heart Failure (CHF) (Telmisartan vs. Placebo Only) | Trial comparisons |
| Aspirin + Extended Release Dipyridamole vs Clopidogrel: Composite Outcome of Stroke, Myocardial Infarction (MI), or Vascular Death (Antiplatelet Comparison Only) | Trial comparisons |
| Aspirin + Extended Release Dipyridamole vs Clopidogrel: Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only) | Trial comparisons |
Tests0
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/NCT00153062
GET https://conductscience.org/api/trials/v1/NCT00153062/events?page=2