STRATAGEM: Strategy for Managing Antiplatelet Therapy in the Perioperative Period of Non Coronary Surgery

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Sanofi-Synthelabo
• Treatments: Aspirin

Criteria

Inclusion Criteria:

• Written informed consent

• Patients over eighteen years of age

• Patients treated with oral antiplatelet agents for secondary prevention (i.e. established and symptomatic cardiovascular disease):

• regardless of the reason (coronary artery disease, stroke or TIA [transient ischemic attack], peripheral arterial disease)

• regardless of the antiplatelet agent (aspirin, clopidogrel, ticlopidine, dipyridamole).

• Patients scheduled for intermediate or high-risk surgery, including but not limited to:

• any long procedure associated with hemodynamic variations or major blood loss

• valvular surgery

• thoracic surgery

• orthopedic surgery

• general (intraperitoneal) surgery

• urological surgery

• vascular surgery

• ear, nose, and throat (ENT) cancerology-related surgery.

Exclusion Criteria:

• Coronary bypass grafting surgery

• History of thrombocytopenia or allergy to heparin

• Arterial stent placement within the previous 30 days

• Active bleeding

• Formal contraindication to the use of anticoagulants and aspirin

• Recent acute coronary syndrome

• Ophthalmological surgery (posterior chamber)

• Neurosurgery

• Emergency surgery

• Thrombotic or bleeding risk deemed unacceptable by the surgical and anesthetic team

• Pregnancy