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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
ClinicalTrials.gov Identifier:
NCT00153062
First received: September 9, 2005
Last updated: April 22, 2014
Last verified: April 2014

September 9, 2005
April 22, 2014
August 2003
April 2008   (final data collection date for primary outcome measure)
  • 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 ]
time to first recurrent stroke of any type, fatal or non-fatal
Complete list of historical versions of study NCT00153062 on ClinicalTrials.gov Archive Site
  • 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 ]
vascular events (stroke, MI, or vascular death); vascular events or CHF; Hemorrhagic events (major & minor); other designated vascular events such as PE, DVT,TIA; new CHF; mortality; thrombocytopenia; neutropenia; new onset diabetes; QOL assessment
Not Provided
Not Provided
 
PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes
PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes: A Double-blind, Active and Placebo Controlled Study of Aggrenox vs. Clopidogrel, With and Without Micardis

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Stroke
  • Drug: Aggrenox
    25mg aspirin, 200 mg dipyridamole
  • Drug: Clopidogrel placebo
    placebo
  • Drug: Micardis
    80 mg micardis
  • Drug: Aggrenox placebo
    placebo
  • Drug: Clopidogrel
    75 mg clopidogrel
  • Drug: Micardis placebo
    placebo
  • Placebo Comparator: Aggrenox, Clopidogrel placebo, Micardis
    Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis (80mg) qd
    Interventions:
    • Drug: Aggrenox
    • Drug: Clopidogrel placebo
    • Drug: Micardis
  • Placebo Comparator: Aggrenox placebo, clopidogrel,, Micardis
    Clopidogrel (75mg) qd; Aggrenox placebo bid, Micardis (80mg) qd
    Interventions:
    • Drug: Micardis
    • Drug: Aggrenox placebo
    • Drug: Clopidogrel
  • Placebo Comparator: Aggrenox, clop placebo, micardis placebo
    Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis placebo qd
    Interventions:
    • Drug: Aggrenox
    • Drug: Clopidogrel placebo
    • Drug: Micardis placebo
  • Placebo Comparator: Aggrenox plcebo, clop, micardis placebo
    Clopidogrel (75mg) qd, Aggrenox placebo bid, Micardis placebo qd.
    Interventions:
    • Drug: Aggrenox placebo
    • Drug: Clopidogrel
    • Drug: Micardis placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20332
Not Provided
April 2008   (final data collection date for primary outcome measure)

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.

Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   China,   Denmark,   El Salvador,   Finland,   France,   Germany,   Greece,   Hong Kong,   India,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   Norway,   Portugal,   Russian Federation,   Singapore,   South Africa,   Spain,   Sweden,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom
 
NCT00153062
9.159
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
  • GlaxoSmithKline
  • Bayer
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP