PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes

Boehringer Ingelheim

Status and phase: Completed; Phase 4

Conditions: Stroke

Treatments: Drug: Aggrenox placebo; Drug: Aggrenox; Drug: Micardis; Drug: Clopidogrel; Drug: Clopidogrel placebo; Drug: Micardis placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00153062

9.159

Details and patient eligibility

About

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.

Enrollment: 20,332 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20,332 participants in 4 patient groups, including a placebo group

Aggrenox, Clopidogrel placebo, Micardis

Placebo Comparator group

Description:

Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis (80mg) qd

Treatment:

Drug: Clopidogrel placebo

Drug: Micardis

Drug: Aggrenox

Aggrenox placebo, clopidogrel,, Micardis

Placebo Comparator group

Description:

Clopidogrel (75mg) qd; Aggrenox placebo bid, Micardis (80mg) qd

Treatment:

Drug: Clopidogrel

Drug: Micardis

Drug: Aggrenox placebo

Aggrenox, clop placebo, micardis placebo

Placebo Comparator group

Description:

Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis placebo qd

Treatment:

Drug: Micardis placebo

Drug: Clopidogrel placebo

Drug: Aggrenox

Aggrenox plcebo, clop, micardis placebo

Placebo Comparator group

Description:

Clopidogrel (75mg) qd, Aggrenox placebo bid, Micardis placebo qd.

Treatment:

Drug: Micardis placebo

Drug: Clopidogrel

Drug: Aggrenox placebo