Posted on April 10: McMaster leads landmark trial in prevention of vascular events in patients with atrial fibrillation

Patient enrolment will soon begin in the ACTIVE trial (Atrial fibrillation Clopidogrel Trial with Irbesartan for the prevention of Vascular Events), the largest randomised trial program ever conducted in atrial fibrillation.

“The ACTIVE trial is intended to respond to a largely unmet medical need in the treatment of patients with atrial fibrillation (AF), who are at an increased risk of life-threatening vascular events such as stroke, myocardial infarction and death,” said Stuart Connolly, professor of medicine at McMaster, and principal investigator of the ACTIVE trial. “Current treatment with oral anticoagulants is not suitable for many AF patients since it is limited by specific contraindications, monitoring constraints and poor compliance.

Aspirin, the only standard alternative to oral anticoagulants, provides only modest protection in this patient population.”

Salim Yusuf, professor of medicine and director of the Population Health Research Institute at McMaster, is chair of the ACTIVE Steering Committee.

The multicentre, multinational ACTIVE trial includes three primary objectives in investigating the long-term efficacy and safety of clopidogrel plus ASA for the prevention of vascular events in patients with atrial fibrillation.

Clopidogrel plus aspirin, which inhibits platelet aggregation, will be compared with standard oral anticoagulant therapy in one trial (ACTIVE W), and compared with ASA alone in a second trial (ACTIVE A). The goal of treatment is the prevention of vascular events in patients with AF.

A third integrated trial is also evaluating whether the angiotensin II receptor antagonist, irbesartan, is superior to placebo (in addition to usual blood pressure lowering therapy) in preventing vascular events in patients with atrial fibrillation (ACTIVE I).

“ACTIVE will provide important information on the potentially broader protection provided by clopidogrel on top of standard therapy including aspirin in this patient population and its potential efficiency in a broader spectrum of patients at risk of blood clots. It will also show whether irbesartan can reduce vascular events in AF patients by angiotensin receptor blockade and by lowering blood pressure,” Connolly added.

The trial, scheduled to begin in April 2003, will enrol approximately 14,000 patients at 600 centres in 30 countries worldwide, and is projected to last 24 months.

Atrial fibrillation is a complex arrhythmia, which is challenging to manage. It is characterized as disordered electrical energy that travels in spinning “wavelets” throughout the upper chambers of the heart, known as the atria, causing them to quiver or fibrillate. It is the most common of the serious chronic cardiac rhythm disturbance and it is responsible for a substantial amount of morbidity, disability and mortality in the general population. Treatment of AF includes slowing or correcting the rhythm disturbance and therapy to prevent thromboembolic complications.

The prevalence of AF in the adult population (approximately 1 per cent worldwide) doubles with each advancing decade of age. The chief hazard of AF is a cardiogenic thromboembolism, increasing the risk of a stroke four- to five-fold. Survival is also seriously reduced, with mortality rates doubled across a wide age range.

The ACTIVE study is supported by a grant from Sanofi-Synthelabo and Bristol-Myers Squibb Company.

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Patient enrolment will soon begin in the ACTIVE trial (Atrial fibrillation Clopidogrel Trial with Irbesartan for the prevention of Vascular Events), the largest randomised trial program ever conducted in atrial fibrillation. <p><br />
<br />
"The ACTIVE trial is intended to respond to a largely unmet medical need in the treatment of patients with atrial fibrillation (AF), who are at an increased risk of life-threatening vascular events such as stroke, myocardial infarction and death," said Stuart Connolly, professor of medicine at McMaster, and principal investigator of the ACTIVE trial.  "Current treatment with oral anticoagulants is not suitable for many AF patients since it is limited by specific contraindications, monitoring constraints and poor compliance. <p><br />
<br />
Aspirin, the only standard alternative to oral anticoagulants, provides only modest protection in this patient population." <p><br />
<br />
Salim Yusuf, professor of medicine and director of the Population Health Research Institute at McMaster, is chair of the ACTIVE Steering Committee. <p><br />
<br />
The multicentre, multinational ACTIVE trial includes three primary objectives in investigating the long-term efficacy and safety of clopidogrel plus ASA for the prevention of vascular events in patients with atrial fibrillation. <p><br />
<br />
Clopidogrel plus aspirin, which inhibits platelet aggregation, will be compared with standard oral anticoagulant therapy in one trial (ACTIVE W), and compared with ASA alone in a second trial (ACTIVE A). The goal of treatment is the prevention of vascular events in patients with AF.  <p><br />
<br />
A third integrated trial is also evaluating whether the angiotensin II receptor antagonist, irbesartan, is superior to placebo (in addition to usual blood pressure lowering therapy) in preventing vascular events in patients with atrial fibrillation (ACTIVE I).<p><br />
<br />
"ACTIVE will provide important information on the potentially broader protection provided by clopidogrel on top of standard therapy including aspirin in this patient population and its potential efficiency in a broader spectrum of patients at risk of blood clots.  It will also show whether irbesartan can reduce vascular events in AF patients by angiotensin receptor blockade and by lowering blood pressure," Connolly added.<p><br />
<br />
The trial, scheduled to begin in April 2003, will enrol approximately 14,000 patients at 600 centres in 30 countries worldwide, and is projected to last 24 months. <p><br />
<br />
Atrial fibrillation is a complex arrhythmia, which is challenging to manage. It is characterized as disordered electrical energy that travels in spinning "wavelets" throughout the upper chambers of the heart, known as the atria, causing them to quiver or fibrillate. It is the most common of the serious chronic cardiac rhythm disturbance and it is responsible for a substantial amount of morbidity, disability and mortality in the general population. Treatment of AF includes slowing or correcting the rhythm disturbance and therapy to prevent thromboembolic complications.<p><br />
<br />
The prevalence of AF in the adult population (approximately 1 per cent worldwide) doubles with each advancing decade of age.  The chief hazard of AF is a cardiogenic thromboembolism, increasing the risk of a stroke four- to five-fold.  Survival is also seriously reduced, with mortality rates doubled across a wide age range.<p><br />
<br />
The ACTIVE study is supported by a grant from Sanofi-Synthelabo and Bristol-Myers Squibb Company.  <p>

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