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Sponsors and Collaborators: |
Assistance Publique - Hôpitaux de Paris Sanofi-Synthelabo |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00190307 |
There is little evidence to guide antiplatelet therapy in patients at high risk of atherothrombotic events undergoing non cardiac surgery. Specifically, it is uncertain whether patients currently on antiplatelet therapy should continue or not continue treatment in the perioperative period.
Aim: To determine an evidence-based strategy for managing antiplatelet therapy in the perioperative period.
Methods: The STRATAGEM trial is an investigator-driven French nationwide multicenter, randomized, double-blind, placebo-controlled trial comparing perioperative low-dose aspirin therapy versus placebo in the perioperative period in patients with documented symptomatic stable atherothrombotic disease taking antiplatelet therapy and undergoing non-coronary surgery. The trial will involve 1500 patients at high risk of atherothrombosis, currently receiving long-term antiplatelet therapy and scheduled for non-coronary surgery in 50 centers. Ten days prior to surgery, patients will discontinue antiplatelet therapy and be randomly assigned to either 75 mg of aspirin or matching placebo for 10 days up to the surgical procedure. Usual therapy will be resumed after surgery according to local practice.
The main outcome measure will be a composite endpoint at day 30 reflecting serious perioperative complications, i.e. total mortality, severe ischemic events (ischemic stroke, non-fatal myocardial infarction [MI], acute limb ischemia, clinical deep venous thrombosis) and/or major hemorrhage (life-threatening bleeding or conducive to revision, or redo surgery, cerebral hemorrhage, intra- or retroperitoneal bleeding, bleeding resulting in the transfusion of more than 2 units of packed red blood cells). The hypothesis to be tested is that low-dose aspirin is associated with a net clinical benefit compared to placebo in the prevention of severe perioperative thrombotic and hemorrhagic complications.
Condition | Intervention | Phase |
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Thrombosis |
Drug: aspirin 75 mg/day |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 1500 |
Study Start Date: | June 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients treated with oral antiplatelet agents for secondary prevention (i.e. established and symptomatic cardiovascular disease):
Patients scheduled for intermediate or high-risk surgery, including but not limited to:
Exclusion Criteria:
Contact: Nathalie Garin | 33 1 40 25 73 85 | nathalie.garin@bch.aphp.fr |
Contact: Florence Tubach, MD | 33 1 40 25 62 54 | florence.tubach@bch.aphp.fr |
France | |
Hôpital Beaujon | Recruiting |
Clichy, France, 92110 | |
Contact: Jean Mantz, MD 33 1 40 87 59 11 jean.mantz@bjn.aphp.fr | |
Contact: Souhayl Dahmani, MD 33 1 40 87 59 11 souhayl.dahmani@bjn.aphp.fr | |
Principal Investigator: Jean Mantz, MD |
Principal Investigator: | Jean Mantz, MD | Hôpital Beaujon, Assistance Publique - Hôpitaux de Paris |
Study ID Numbers: | P030440, AOM 03026 |
Study First Received: | September 12, 2005 |
Last Updated: | September 27, 2006 |
ClinicalTrials.gov Identifier: | NCT00190307 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Long term antiplatelet therapy Scheduled surgery |
Embolism and Thrombosis Aspirin Embolism Vascular Diseases Thrombosis |
Cardiovascular Diseases |