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PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Bayer
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00153062
First received: September 9, 2005
Last updated: May 30, 2012
Last verified: May 2012
History of Changes
Results First Received: February 6, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Prevention
Condition: Stroke
Interventions: Drug: Aggrenox
Drug: Clopidogrel placebo
Drug: Micardis
Drug: Aggrenox placebo
Drug: Clopidogrel
Drug: Micardis placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Sept 2003 - July 2006; 695 centres in 35 countries

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No screening period

Reporting Groups
  Description
Aspirin + Extended Release Dipyridamole / Telmisartan 25 milligrams (mg) aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / telmisartan 80 mg, once daily, tablet
Aspirin + Extended Release Dipyridamole / Placebo 25 mg aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / placebo tablet
Clopidogrel / Telmisartan clopidogrel 75 mg, once daily, tablet / telmisartan 80 mg, once daily, tablet
Clopidogrel / Placebo clopidogrel 75 mg, once daily, tablet / placebo tablet

Participant Flow:   Overall Study
    Aspirin + Extended Release Dipyridamole / Telmisartan     Aspirin + Extended Release Dipyridamole / Placebo     Clopidogrel / Telmisartan     Clopidogrel / Placebo  
STARTED     5086     5095     5060     5091  
COMPLETED     4699     4689     4645     4680  
NOT COMPLETED     387     406     415     411  
Death                 360                 352                 369                 365  
Withdrawal by Subject                 14                 30                 27                 28  
Lost to Follow-up                 12                 20                 15                 16  
Adverse Event                 0                 1                 1                 0  
Protocol Violation                 0                 2                 1                 1  
No disposition data available                 1                 1                 1                 1  
Unknown                 0                 0                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Aspirin + Extended Release Dipyridamole / Telmisartan 25 milligrams (mg) aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / telmisartan 80 mg, once daily, tablet
Aspirin + Extended Release Dipyridamole / Placebo 25 mg aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / placebo tablet
Clopidogrel / Telmisartan clopidogrel 75 mg, once daily, tablet / telmisartan 80 mg, once daily, tablet
Clopidogrel / Placebo clopidogrel 75 mg, once daily, tablet / placebo tablet
Total Total of all reporting groups

Baseline Measures
    Aspirin + Extended Release Dipyridamole / Telmisartan     Aspirin + Extended Release Dipyridamole / Placebo     Clopidogrel / Telmisartan     Clopidogrel / Placebo     Total  
Number of Participants  
[units: participants]
 		  5086     5095     5060     5091     20332  
Age  
[units: years]
Mean ± Standard Deviation 		  66.0  ± 8.5     66.2  ± 8.6     66.2  ± 8.6     66.2  ± 8.5     66.1  ± 8.6  
Gender  
[units: Participants]
 		         
Female     1802     1851     1817     1840     7310  
Male     3284     3244     3243     3251     13022  



  Outcome Measures
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1.  Primary:   Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only)   [ Time Frame: time since randomization; follow-up period is 1.5 to 4.4 years ]
  Show Outcome Measure 1

2.  Primary:   Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only)   [ Time Frame: time since randomization; follow-up period is 1.5 to 4.4 years ]
  Show Outcome Measure 2

3.  Secondary:   Composite Outcome of Stroke, Myocardial Infarction (MI), or Vascular Death (Antiplatelet Comparison Only)   [ Time Frame: time since randomization; follow-up period is 1.5 to 4.4 years ]
  Show Outcome Measure 3

4.  Secondary:   Composite Outcome of Stroke, Myocardial Infarction, Vascular Death, or New or Worsening Congestive Heart Failure (CHF) (Telmisartan vs. Placebo Only)   [ Time Frame: time since randomization; follow-up period is 1.5 to 4.4 years ]
  Show Outcome Measure 4

5.  Secondary:   Number of Patients With New Onset of Diabetes (Telmisartan vs. Placebo Only)   [ Time Frame: Randomization to final patient contact ]
  Show Outcome Measure 5


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Treated Set of patients is used for Serious Adverse Events and Other Adverse Events analysis of Headache leading to permanent discontinuation. Randomized Set of patients is used for Dizziness assessed at Day 7 and Headache assessed at Day 7.  


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided by Boehringer Ingelheim Pharmaceuticals

Publications automatically indexed to this study:
Diener HC, Sacco RL, Yusuf S, Cotton D, Ounpuu S, Lawton WA, Palesch Y, Martin RH, Albers GW, Bath P, Bornstein N, Chan BP, Chen ST, Cunha L, Dahlöf B, De Keyser J, Donnan GA, Estol C, Gorelick P, Gu V, Hermansson K, Hilbrich L, Kaste M, Lu C, Machnig T, Pais P, Roberts R, Skvortsova V, Teal P, Toni D, VanderMaelen C, Voigt T, Weber M, Yoon BW; Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) study group. Effects of aspirin plus extended-release dipyridamole versus clopidogrel and telmisartan on disability and cognitive function after recurrent stroke in patients with ischaemic stroke in the Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) trial: a double-blind, active and placebo-controlled study. Lancet Neurol. 2008 Oct;7(10):875-84. Epub 2008 Aug 29.


Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00153062     History of Changes
Other Study ID Numbers: 9.159
Study First Received: September 9, 2005
Results First Received: February 6, 2009
Last Updated: May 30, 2012
Health Authority: Argentina: Ministry of Health
Australia: Dept of Health and Ageing Therapeutic Goods Admin
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal and Health Products
Brazil: National Health Surveillance Agency
Canada: Health Canada
China: Ministry of Health
Denmark: National Board of Health
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Ministry of Health
Greece: Ministry of Health and Welfare
Hong Kong: Department of Health
India: Ministry of Health
Ireland: Irish Medicines Board
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ministry of Health
Japan: Pharmaceuticals and Medical Devices Agency
Korea: Food and Drug Administration
Malaysia: Ministry of Health
Mexico: Ministry of Health
Netherlands: Dutch Health Care Inspectorate
Norway: Norwegian Medicines Agency
Portugal: National Pharmacy and Medicines Institute
Russia: Pharmacological Committee, Ministry of Health
Singapore: Health Sciences Authority
South Africa: Department of Health
Spain: Ministry of Health
Sweden: The National Board of Health and Welfare
Taiwan: Department of Health
Thailand: Ministry of Public Health
Turkey: Ministry of Health Central Ethics Committee
Ukraine: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration