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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00153062




Registration number
NCT00153062
Ethics application status
Date submitted
9/09/2005
Date registered
12/09/2005
Date last updated
13/05/2014

Titles & IDs
Public title
PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes
Scientific 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
Secondary ID [1] 0 0
9.159
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Aggrenox
Treatment: Drugs - Aggrenox
Treatment: Drugs - Clopidogrel placebo
Treatment: Drugs - Clopidogrel placebo
Treatment: Drugs - Micardis
Treatment: Drugs - Micardis
Treatment: Drugs - Aggrenox placebo
Treatment: Drugs - Aggrenox placebo
Treatment: Drugs - Clopidogrel
Treatment: Drugs - Clopidogrel
Treatment: Drugs - Micardis placebo
Treatment: Drugs - Micardis placebo

Placebo comparator: Aggrenox, Clopidogrel placebo, Micardis - Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis (80mg) qd

Placebo comparator: Aggrenox placebo, clopidogrel,, Micardis - Clopidogrel (75mg) qd; Aggrenox placebo bid, Micardis (80mg) qd

Placebo comparator: Aggrenox, clop placebo, micardis placebo - Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis placebo qd

Placebo comparator: Aggrenox plcebo, clop, micardis placebo - Clopidogrel (75mg) qd, Aggrenox placebo bid, Micardis placebo qd.


Treatment: Drugs: Aggrenox
25mg aspirin, 200 mg dipyridamole

Treatment: Drugs: Aggrenox
25mg aspirin, 200 mg dipyridamole

Treatment: Drugs: Clopidogrel placebo
placebo

Treatment: Drugs: Clopidogrel placebo
placebo

Treatment: Drugs: Micardis
80 mg micardis

Treatment: Drugs: Micardis
80 mg micardis

Treatment: Drugs: Aggrenox placebo
placebo

Treatment: Drugs: Aggrenox placebo
placebo

Treatment: Drugs: Clopidogrel
75 mg clopidogrel

Treatment: Drugs: Clopidogrel
75 mg clopidogrel

Treatment: Drugs: Micardis placebo
placebo

Treatment: Drugs: Micardis placebo
placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only)
Timepoint [1] 0 0
time since randomization; follow-up period is 1.5 to 4.4 years
Primary outcome [2] 0 0
Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only)
Timepoint [2] 0 0
time since randomization; follow-up period is 1.5 to 4.4 years
Secondary outcome [1] 0 0
Composite Outcome of Stroke, Myocardial Infarction (MI), or Vascular Death (Antiplatelet Comparison Only)
Timepoint [1] 0 0
time since randomization; follow-up period is 1.5 to 4.4 years
Secondary outcome [2] 0 0
Composite Outcome of Stroke, Myocardial Infarction, Vascular Death, or New or Worsening Congestive Heart Failure (CHF) (Telmisartan vs. Placebo Only)
Timepoint [2] 0 0
time since randomization; follow-up period is 1.5 to 4.4 years
Secondary outcome [3] 0 0
Number of Patients With New Onset of Diabetes (Telmisartan vs. Placebo Only)
Timepoint [3] 0 0
Randomization to final patient contact

Eligibility
Key inclusion 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
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
20332
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
9.159.2444 Boehringer Ingelheim Investigational Site - Gosford
Recruitment hospital [2] 0 0
9.159.2449 Boehringer Ingelheim Investigational Site - New Lambton
Recruitment hospital [3] 0 0
9.159.2448 Boehringer Ingelheim Investigational Site - Westmead
Recruitment hospital [4] 0 0
9.159.2450 Boehringer Ingelheim Investigational Site - Herston
Recruitment hospital [5] 0 0
9.159.2452 Boehringer Ingelheim Investigational Site - Southport
Recruitment hospital [6] 0 0
9.159.2451 Boehringer Ingelheim Investigational Site - Bedford Park
Recruitment hospital [7] 0 0
9.159.2443 Boehringer Ingelheim Investigational Site - Box Hill
Recruitment hospital [8] 0 0
9.159.2447 Boehringer Ingelheim Investigational Site - Melbourne
Recruitment hospital [9] 0 0
9.159.2445 Boehringer Ingelheim Investigational Site - Parkville
Recruitment hospital [10] 0 0
9.159.2446 Boehringer Ingelheim Investigational Site - West Heidelberg
Recruitment postcode(s) [1] 0 0
- Gosford
Recruitment postcode(s) [2] 0 0
- New Lambton
Recruitment postcode(s) [3] 0 0
- Westmead
Recruitment postcode(s) [4] 0 0
- Herston
Recruitment postcode(s) [5] 0 0
- Southport
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- Bedford Park
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- Box Hill
Recruitment postcode(s) [8] 0 0
- Melbourne
Recruitment postcode(s) [9] 0 0
- Parkville
Recruitment postcode(s) [10] 0 0
- West Heidelberg
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
GlaxoSmithKline
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Bayer
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00153062
Trial related presentations / publications
Ovbiagele B, Bath PM, Cotton D, Sha N, Diener HC; PRoFESS Investigators. Low glomerular filtration rate, recurrent stroke risk, and effect of renin-angiotensin system modulation. Stroke. 2013 Nov;44(11):3223-5. doi: 10.1161/STROKEAHA.113.002463. Epub 2013 Aug 29.
Bohm M, Cotton D, Foster L, Custodis F, Laufs U, Sacco R, Bath PM, Yusuf S, Diener HC. Impact of resting heart rate on mortality, disability and cognitive decline in patients after ischaemic stroke. Eur Heart J. 2012 Nov;33(22):2804-12. doi: 10.1093/eurheartj/ehs250. Epub 2012 Aug 26.
Weber R, Weimar C, Blatchford J, Hermansson K, Wanke I, Moller-Hartmann C, Gizewski ER, Forsting M, Demchuk AM, Sacco RL, Saver JL, Warach S, Diener HC, Diehl A; PRoFESS Imaging Substudy Group. Telmisartan on top of antihypertensive treatment does not prevent progression of cerebral white matter lesions in the prevention regimen for effectively avoiding second strokes (PRoFESS) MRI substudy. Stroke. 2012 Sep;43(9):2336-42. doi: 10.1161/STROKEAHA.111.648576. Epub 2012 Jun 26.
Weber R, Weimar C, Wanke I, Moller-Hartmann C, Gizewski ER, Blatchford J, Hermansson K, Demchuk AM, Forsting M, Sacco RL, Saver JL, Warach S, Diener HC, Diehl A; PRoFESS Imaging Substudy Group. Risk of recurrent stroke in patients with silent brain infarction in the Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) imaging substudy. Stroke. 2012 Feb;43(2):350-5. doi: 10.1161/STROKEAHA.111.631739. Epub 2012 Jan 19.
Ovbiagele B, Diener HC, Yusuf S, Martin RH, Cotton D, Vinisko R, Donnan GA, Bath PM; PROFESS Investigators. Level of systolic blood pressure within the normal range and risk of recurrent stroke. JAMA. 2011 Nov 16;306(19):2137-44. doi: 10.1001/jama.2011.1650.
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, Dahlof 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. doi: 10.1016/S1474-4422(08)70198-4. Epub 2008 Aug 29. Erratum In: Lancet Neurol. 2008 Nov;7(11):985.
Yusuf S, Diener HC, Sacco RL, Cotton D, Ounpuu S, Lawton WA, Palesch Y, Martin RH, Albers GW, Bath P, Bornstein N, Chan BP, Chen ST, Cunha L, Dahlof 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; PRoFESS Study Group. Telmisartan to prevent recurrent stroke and cardiovascular events. N Engl J Med. 2008 Sep 18;359(12):1225-37. doi: 10.1056/NEJMoa0804593. Epub 2008 Aug 27.
Sacco RL, Diener HC, Yusuf S, Cotton D, Ounpuu S, Lawton WA, Palesch Y, Martin RH, Albers GW, Bath P, Bornstein N, Chan BP, Chen ST, Cunha L, Dahlof 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; PRoFESS Study Group. Aspirin and extended-release dipyridamole versus clopidogrel for recurrent stroke. N Engl J Med. 2008 Sep 18;359(12):1238-51. doi: 10.1056/NEJMoa0805002. Epub 2008 Aug 27.
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00153062