STRATAGEM: Strategy for Managing Antiplatelet Therapy in the Perioperative Period of Non Coronary Surgery
Summary
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.
Description
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.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
Conditions
Thrombosis
Intervention
aspirin 75 mg/day
Location
Hôpital Beaujon
Clichy
France
92110
Status
Completed
Source
Assistance Publique - Hôpitaux de Paris
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00190307
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Aspirin
The prototypical analgesic used in the treatment of mild to moderate pain. It has anti-inflammatory and antipyretic properties and acts as an inhibitor of cyclooxygenase which results in the inhibition of the biosynthesis of prostaglandins. Aspirin also inhibits platelet aggregation and is used in the prevention of arterial and venous thrombosis. (From Martindale, The Extra Pharmacopoeia, 30th ed, p5)
Sodium Salicylate
A non-steroidal anti-inflammatory agent that is less effective than equal doses of ASPIRIN in relieving pain and reducing fever. However, individuals who are hypersensitive to ASPIRIN may tolerate sodium salicylate. In general, this salicylate produces the same adverse reactions as ASPIRIN, but there is less occult gastrointestinal bleeding. (From AMA Drug Evaluations Annual, 1992, p120)
Asthma, Aspirin-induced
Asthmatic adverse reaction (e.g., BRONCHOCONSTRICTION) to conventional NSAIDS including aspirin use.
Intracranial Embolism And Thrombosis
Embolism or thrombosis involving blood vessels which supply intracranial structures. Emboli may originate from extracranial or intracranial sources. Thrombosis may occur in arterial or venous structures.
Upper Extremity Deep Vein Thrombosis
DEEP VEIN THROMBOSIS of an upper extremity vein (e.g., AXILLARY VEIN; SUBCLAVIAN VEIN; and JUGULAR VEINS). It is associated with mechanical factors (Upper Extremity Deep Vein Thrombosis, Primary) secondary to other anatomic factors (Upper Extremity Deep Vein Thrombosis, Secondary). Symptoms may include sudden onset of pain, warmth, redness, blueness, and swelling in the arm.
Clinical Trials
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PubMed Articles
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Aspirin is conventionally regarded as an agent that prevents arterial thrombosis, an effect mediated through inhibition of platelet cyclooxygenase-1, resulting in decreased synthesis of thromboxane A(...
Can resistance to aspirin be reversed after an additional dose?
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24-hour time-dependent aspirin efficacy in patients with stable coronary artery disease.
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