PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Bayer
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00153062
First received: September 9, 2005
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

The purpose of the trial is to determine if extended-release dipyridamole + aspirin [Aggrenox, Asasa ntin] is superior to clopidogrel [Plavix], and if telmisartan [Micardis, Gliosartan, Kinzal, Kinzalm ono, Predxal, Pritor, Samertan, Telmisartan] is superior to placebo, in the presence of background antihypertensive therapy, in prevention of a second stroke in patients who have recently suffered a stroke and therefore are at high risk of suffering another one.


Condition Intervention Phase
Stroke
Drug: Aggrenox
Drug: Clopidogrel placebo
Drug: Micardis
Drug: Aggrenox placebo
Drug: Clopidogrel
Drug: Micardis placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes: A Double-blind, Active and Placebo Controlled Study of Aggrenox vs. Clopidogrel, With and Without Micardis

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ]
  • 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 ]

Secondary Outcome Measures:
  • 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 ]
    Number of patients with any of stroke, myocardial infarction, vascular death

  • 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 ]
    Number of patients with any of stroke, myocardial infarction, vascular death, or new or worsening congestive heart failure

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

Enrollment: 20332
Study Start Date: August 2003
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Aggrenox, Clopidogrel placebo, Micardis
Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis (80mg) qd
Drug: Aggrenox
25mg aspirin, 200 mg dipyridamole
Drug: Clopidogrel placebo
placebo
Drug: Micardis
80 mg micardis
Placebo Comparator: Aggrenox placebo, clopidogrel,, Micardis
Clopidogrel (75mg) qd; Aggrenox placebo bid, Micardis (80mg) qd
Drug: Micardis
80 mg micardis
Drug: Aggrenox placebo
placebo
Drug: Clopidogrel
75 mg clopidogrel
Placebo Comparator: Aggrenox, clop placebo, micardis placebo
Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis placebo qd
Drug: Aggrenox
25mg aspirin, 200 mg dipyridamole
Drug: Clopidogrel placebo
placebo
Drug: Micardis placebo
placebo
Placebo Comparator: Aggrenox plcebo, clop, micardis placebo
Clopidogrel (75mg) qd, Aggrenox placebo bid, Micardis placebo qd.
Drug: Aggrenox placebo
placebo
Drug: Clopidogrel
75 mg clopidogrel
Drug: Micardis placebo
placebo

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Male or female subjects 55 year or older who have suffered an ischemic stroke within the past 90 days and who meet all other inclusion criteria. Include also patients of ages 50 - 54 years and/or 90 to 120 days after the qualifying stroke provided the patient has at least two of the following additional risk factors:

  • Diabetes mellitus
  • Hypertension (systolic BP ¿ 140 or diastolic BP ¿ 90)
  • Smoker at time of qualifying stroke
  • Obesity (BMI>30; BMI=weight (kg)/[height (m)]2)
  • Previous vascular disease (stroke, MI, or peripheral arterial disease prior to qualifying stroke)
  • End-organ-damage (retinopathy, LVH, or microalbuminuria)
  • Hyperlipidemia

Exclusion criteria:

hemorrhagic stroke (must be ruled out by imaging);unable to give informed consent; known brain tumor, severe renal or hepatic insufficiency, current active peptic ulcer disease, severe coronary artery disease including unstable angina pectoris or an MI within the previous 3 months,or history of a hemostatic disorder or systemic bleeding ;hyperkalemia;uncorrected volume or sodium depletion; pre-stroke history of dementia;modified Rankin score greater than 4;qualifying stroke induced by surgical or cardiovascular procedure;uncontrolled hypertension at entry above 180/110 mmHg (goal BPs are lower); SBP 120 mmHg or less for hospitalized patients; currently taking an ARB and not able or willing to switch to alternative; required or planned continuing treatment with antithrombotics or anticoagulants including heparin or warfarin or non-study platelet inhibitors; syndrome of asthma, rhinitis and nasal polyps;scheduled for major surgery, carotid endarterectomy, or carotid angioplasty (4 weeks post surgery is allowed);unlikely to be released from hospital following the qualifying stroke or presence of a severe disability likely to lead to being bedridden or demented or a non-vascular disease or condition which makes it unlikely that the patient will survive to the end of the trial; history of thrombocytopenia or neutropenia.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00153062

  Show 667 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
GlaxoSmithKline
Bayer
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
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: April 22, 2014
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

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Clopidogrel
Aspirin, dipyridamole drug combination
Ticlopidine
Telmisartan
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers

ClinicalTrials.gov processed this record on October 02, 2014