Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Part of drug trial for patients with atrial fibrillation discontinued

07.09.2005


ACTIVE-A and ACTIVE-I to continue



Study treatments for the ACTIVE W trial of the ACTIVE (Atrial Fibrillation Clopidogrel Trial with Irbesartan for Prevention of Vascular Events) program have been discontinued due to a significant difference in efficacy, in favour of the standard oral anticoagulation (OAC) over antiplatelet therapy (clopidogrel plus aspirin).

The ACTIVE trial, the largest randomised international trial program ever conducted in atrial fibrillation (AF), was designed to respond to a largely unmet medical need in the treatment of patients with AF, who are at an increased risk of life-threatening vascular events such as stroke, myocardial infarction and death.


Investigators at 600 sites will adjust their patients’ medications and continue to monitor their health. Approximately 3,000 patients worldwide will be affected by the changes in the study.

After an interim analysis of the study, the recommendation of an independent Data Safety Monitoring Board to discontinue the ACTIVE W trial was endorsed by the ACTIVE study steering committee.

The board also recommended two other trials of the ACTIVE program be continued. The study’s steering committee agreed with the recommendation to discontinue study treatments for ACTIVE W, and endorsed the recommendation to continue the ACTIVE A (clopidogrel compared with ASA alone), and ACTIVE I (irbesartan to placebo in addition to usual blood pressure lowering therapy).

"In the ACTIVE W trial, most of the patients had been receiving OAC prior to entry into the trial," said SalimYusuf, PhD, chairman of the steering committee for the ACTIVE trial program. "These patients achieved high levels of compliance to OAC in the recommended therapeutic range. In the ACTIVE-W trial, a clear benefit in favour of OAC was evident."

Stuart Connolly, MD, principal investigator of the program, emphasized that: "It is important to continue the ACTIVE A and ACTIVE I parts of the study program to evaluate the potential role which clopidogrel can play in the management of atrial fibrillation patients who are intolerant to oral anticoagulants, and to understand the role of irbesartan in patients with atrial fibrillation."

Clinical guidelines recommend the use of OAC therapy for most patients with atrial fibrillation in order to prevent embolic events. However, OAC therapy is associated with a narrow therapeutic window, requires regular monitoring and is contraindicated in some patients. Aspirin is an option in patients who cannot tolerate OACs. The ACTIVE trial programme is designed to evaluate the appropriate place of clopidogrel plus aspirin in the prevention of embolic events in atrial fibrillation patients.

ACTIVE is a phase III multicenter, multinational clinical development program that includes three trials. In ACTIVE A, clopidogrel plus aspirin is compared with aspirin alone in patients who have a contraindication for OACs or are unwilling to take an OAC, with the hypothesis that clopidogrel plus aspirin would be superior to aspirin. ACTIVE I is 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.

The ACTIVE trial program is being conducted at more than 600 sites worldwide in 30 countries.

Atrial fibrillation is the most common chronic cardiac rhythm disturbance and it is responsible for a substantial amount of morbidity, disability and mortality in the general population.

Veronica McGuire | EurekAlert!
Further information:
http://www.mcmaster.ca

More articles from Health and Medicine:

nachricht The genes are not to blame
20.07.2018 | Technische Universität München

nachricht Targeting headaches and tumors with nano-submarines
20.07.2018 | Universitätsmedizin der Johannes Gutenberg-Universität Mainz

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Future electronic components to be printed like newspapers

A new manufacturing technique uses a process similar to newspaper printing to form smoother and more flexible metals for making ultrafast electronic devices.

The low-cost process, developed by Purdue University researchers, combines tools already used in industry for manufacturing metals on a large scale, but uses...

Im Focus: First evidence on the source of extragalactic particles

For the first time ever, scientists have determined the cosmic origin of highest-energy neutrinos. A research group led by IceCube scientist Elisa Resconi, spokesperson of the Collaborative Research Center SFB1258 at the Technical University of Munich (TUM), provides an important piece of evidence that the particles detected by the IceCube neutrino telescope at the South Pole originate from a galaxy four billion light-years away from Earth.

To rule out other origins with certainty, the team led by neutrino physicist Elisa Resconi from the Technical University of Munich and multi-wavelength...

Im Focus: Magnetic vortices: Two independent magnetic skyrmion phases discovered in a single material

For the first time a team of researchers have discovered two different phases of magnetic skyrmions in a single material. Physicists of the Technical Universities of Munich and Dresden and the University of Cologne can now better study and understand the properties of these magnetic structures, which are important for both basic research and applications.

Whirlpools are an everyday experience in a bath tub: When the water is drained a circular vortex is formed. Typically, such whirls are rather stable. Similar...

Im Focus: Breaking the bond: To take part or not?

Physicists working with Roland Wester at the University of Innsbruck have investigated if and how chemical reactions can be influenced by targeted vibrational excitation of the reactants. They were able to demonstrate that excitation with a laser beam does not affect the efficiency of a chemical exchange reaction and that the excited molecular group acts only as a spectator in the reaction.

A frequently used reaction in organic chemistry is nucleophilic substitution. It plays, for example, an important role in in the synthesis of new chemical...

Im Focus: New 2D Spectroscopy Methods

Optical spectroscopy allows investigating the energy structure and dynamic properties of complex quantum systems. Researchers from the University of Würzburg present two new approaches of coherent two-dimensional spectroscopy.

"Put an excitation into the system and observe how it evolves." According to physicist Professor Tobias Brixner, this is the credo of optical spectroscopy....

All Focus news of the innovation-report >>>

Anzeige

Anzeige

VideoLinks
Industry & Economy
Event News

Leading experts in Diabetes, Metabolism and Biomedical Engineering discuss Precision Medicine

13.07.2018 | Event News

Conference on Laser Polishing – LaP: Fine Tuning for Surfaces

12.07.2018 | Event News

11th European Wood-based Panel Symposium 2018: Meeting point for the wood-based materials industry

03.07.2018 | Event News

 
Latest News

A smart safe rechargeable zinc ion battery based on sol-gel transition electrolytes

20.07.2018 | Power and Electrical Engineering

Reversing cause and effect is no trouble for quantum computers

20.07.2018 | Information Technology

Princeton-UPenn research team finds physics treasure hidden in a wallpaper pattern

20.07.2018 | Materials Sciences

VideoLinks
Science & Research
Overview of more VideoLinks >>>