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 Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

20,332

participants targeted

Target at P75+ for phase_4 stroke

Geographic Reach

35 countries

657 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed

2.1 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

September 2, 2009

Completed

Last Updated

May 13, 2014

Status Verified

April 1, 2014

Enrollment Period

4.7 years

First QC Date

September 9, 2005

Results QC Date

February 6, 2009

Last Update Submit

April 22, 2014

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

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
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 Outcomes (3)

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
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
Number of Patients With New Onset of Diabetes (Telmisartan vs. Placebo Only)
Randomization to final patient contact

Study Arms (4)

Aggrenox, Clopidogrel placebo, Micardis

PLACEBO COMPARATOR

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

Drug: AggrenoxDrug: Clopidogrel placeboDrug: Micardis

Aggrenox placebo, clopidogrel,, Micardis

PLACEBO COMPARATOR

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

Drug: MicardisDrug: Aggrenox placeboDrug: Clopidogrel

Aggrenox, clop placebo, micardis placebo

PLACEBO COMPARATOR

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

Drug: AggrenoxDrug: Clopidogrel placeboDrug: Micardis placebo

Aggrenox plcebo, clop, micardis placebo

PLACEBO COMPARATOR

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

Drug: Aggrenox placeboDrug: ClopidogrelDrug: Micardis placebo

Interventions

AggrenoxDRUG

25mg aspirin, 200 mg dipyridamole

Aggrenox, Clopidogrel placebo, Micardis

Clopidogrel placeboDRUG

placebo

Aggrenox, Clopidogrel placebo, Micardis

MicardisDRUG

80 mg micardis

Aggrenox, Clopidogrel placebo, Micardis

Aggrenox placeboDRUG

placebo

Aggrenox placebo, clopidogrel,, Micardis

ClopidogrelDRUG

75 mg clopidogrel

Aggrenox placebo, clopidogrel,, Micardis

Micardis placeboDRUG

placebo

Aggrenox, clop placebo, micardis placebo

Eligibility Criteria

Age50 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Boehringer Ingelheimlead
GlaxoSmithKlinecollaborator
Bayercollaborator

Study Sites (667)

9.159.1101 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

9.159.1173 Boehringer Ingelheim Investigational Site

Huntsville, Alabama, United States

Location

9.159.1058 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Location

9.159.1087 Boehringer Ingelheim Investigational Site

Montgomery, Alabama, United States

Location

9.159.1081 Boehringer Ingelheim Investigational Site

Northport, Alabama, United States

Location

9.159.1022 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Location

9.159.1133 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Location

9.159.1149 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Location

9.159.1137 Boehringer Ingelheim Investigational Site

Tucson, Arizona, United States

Location

9.159.1184 Boehringer Ingelheim Investigational Site

Fayetteville, Arkansas, United States

Location

9.159.1005 Boehringer Ingelheim Investigational Site

Fort Smith, Arkansas, United States

Location

9.159.1136 Boehringer Ingelheim Investigational Site

Jonesboro, Arkansas, United States

Location

9.159.1062 Boehringer Ingelheim Investigational Site

Little Rock, Arkansas, United States

Location

9.159.1040 Boehringer Ingelheim Investigational Site

Berkeley, California, United States

Location

9.159.1180 Boehringer Ingelheim Investigational Site

Carmichael, California, United States

Location

9.159.1114 Boehringer Ingelheim Investigational Site

Irvine, California, United States

Location

9.159.1202 Boehringer Ingelheim Investigational Site

Laguna Hills, California, United States

Location

9.159.1036 Boehringer Ingelheim Investigational Site