Clinical trial NCT00190307: STRATAGEM: Strategy for Managing Antiplatelet Therapy in the Perioperative Period of Non Coronary Surgery
Official title: Strategy for Managing Antiplatelet Therapy in the Perioperative Period of Non Coronary Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thrombosis
Keywords: Long term antiplatelet therapy
Scheduled surgery
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Sanofi-Synthelabo
First posted: 2005-09-19
Enrollment: 293
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Consisting of major thromboembolic events listed in the following table with their respective weights.
timeFrame: A composite criterion measured at Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Clichy
country: France
facility: Hôpital Beaujon
Study officials:
affiliation: Hôpital Beaujon, Assistance Publique - Hôpitaux de Paris
name: Jean Mantz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mantz J, Samama CM, Tubach F, Devereaux PJ, Collet JP, Albaladejo P, Cholley B, Nizard R, Barre J, Piriou V, Poirier N, Mignon A, Schlumberger S, Longrois D, Aubrun F, Farese ME, Ravaud P, Steg PG; Stratagem Study Group. Impact of preoperative maintenance or interruption of aspirin on thrombotic and bleeding events after elective non-cardiac surgery: the multicentre, randomized, blinded, placebo-controlled, STRATAGEM trial. Br J Anaesth. 2011 Dec;107(6):899-910. doi: 10.1093/bja/aer274. Epub 2011 Aug 27.