PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes

Completed

Phase 4 Results

Trial Description

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.

Conditions

Interventions

  • Clopidogrel (Plavix┬«)Drug
    Other Names: Plavix
    Intervention Desc: 75 mg clopidogrel
    ARM 1: Kind: Experimental
    Label: Clopidogrel / Telmisartan
    ARM 2: Kind: Experimental
    Label: Clopidogrel / Placebo
    ARM 3: Kind: Experimental
    Label: Aggrenox placebo, clopidogrel,, Micardis
    Description: Clopidogrel (75mg) qd; Aggrenox placebo bid, Micardis (80mg) qd
    ARM 4: Kind: Experimental
    Label: Aggrenox plcebo, clop, micardis placebo
    Description: Clopidogrel (75mg) qd, Aggrenox placebo bid, Micardis placebo qd.
  • Dipyridamole (Persantine┬«)Drug
    Intervention Desc: Platelet aggregation inhibitor
  • Antihypertensives Drug
    Intervention Desc: This category includes all BP lowering drugs in stroke prevention trials
  • Aggrenox (Aggrenox)Drug
    Intervention Desc: 25mg aspirin, 200 mg dipyridamole
    ARM 1: Kind: Experimental
    Label: Aggrenox, Clopidogrel placebo, Micardis
    Description: Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis (80mg) qd
    ARM 2: Kind: Experimental
    Label: Aggrenox, clop placebo, micardis placebo
    Description: Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis placebo qd
  • Telmisartan (Micardis® )Drug
    ARM 1: Kind: Experimental
    Label: ASA+ERDP / Telmisartan
    ARM 2: Kind: Experimental
    Label: Clopidogrel / Telmisartan
  • Extended-release dipyridamole + aspirin Drug
    ARM 1: Kind: Experimental
    Label: ASA+ERDP / Telmisartan
    ARM 2: Kind: Experimental
    Label: ASA+ERDP / Placebo
  • Clopidogrel placebo Drug
    Intervention Desc: placebo
    ARM 1: Kind: Experimental
    Label: Aggrenox, Clopidogrel placebo, Micardis
    Description: Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis (80mg) qd
    ARM 2: Kind: Experimental
    Label: Aggrenox, clop placebo, micardis placebo
    Description: Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis placebo qd
  • Micardis Drug
    Intervention Desc: 80 mg micardis
    ARM 1: Kind: Experimental
    Label: Aggrenox, Clopidogrel placebo, Micardis
    Description: Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis (80mg) qd
    ARM 2: Kind: Experimental
    Label: Aggrenox placebo, clopidogrel,, Micardis
    Description: Clopidogrel (75mg) qd; Aggrenox placebo bid, Micardis (80mg) qd
  • Aggrenox placebo Drug
    Intervention Desc: placebo
    ARM 1: Kind: Experimental
    Label: Aggrenox placebo, clopidogrel,, Micardis
    Description: Clopidogrel (75mg) qd; Aggrenox placebo bid, Micardis (80mg) qd
    ARM 2: Kind: Experimental
    Label: Aggrenox plcebo, clop, micardis placebo
    Description: Clopidogrel (75mg) qd, Aggrenox placebo bid, Micardis placebo qd.
  • Micardis placebo Drug
    Intervention Desc: placebo
    ARM 1: Kind: Experimental
    Label: Aggrenox, clop placebo, micardis placebo
    Description: Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis placebo qd
    ARM 2: Kind: Experimental
    Label: Aggrenox plcebo, clop, micardis placebo
    Description: Clopidogrel (75mg) qd, Aggrenox placebo bid, Micardis placebo qd.

Trial Design

  • Allocation: Randomized
  • Masking: Double-Blind
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

18,500 patients will be randomized into one of four treatment groups, in a 2 by 2 factorial design. All patients receive active antiplatelet medication, either clopidogrel or extended-release dipyridamole + aspirin. In addition, half of the patients in each antiplatelet arm will receive telmisartan (an angiotensin receptor blocker or ARB), and half will receive a telmisartan placebo. All hypertensive patients receive open-label antihypertensive medications (such as diuretics, calcium channel blockers, or beta blockers) if necessary to control blood pressure, in addition to the blinded study medication. All study subjects will recieve a physical examination with neurological assessments and study medication for up to 4 years.

Outcomes

Type Measure Time Frame Safety Issue
Primary Time to first recurrent stroke.
Secondary Composite endpoint of vascular events (first non-fatal stroke, non-fatal MI, vascular death). Composite endpoint of other designated vascular events (time to first PE, retinal vascular accident that is not a retinal arterial occlusion, DVT, peripheral arterial occlusion, and stroke type).
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
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
Secondary Number of Patients With New Onset of Diabetes (Telmisartan vs. Placebo Only) Randomization to final patient contact

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