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

Thrombosis Clinical Trial

— STRATAGEM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00190307
• Other study ID #: P030440
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: September 20, 2011
• Start date: June 2005
• Est. completion date: December 2009

Study information

• Verified date: September 2005
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 293
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Thrombosis

Intervention

Drug:
• aspirin 75 mg/day
aspirin 75 mg/day

Locations

Country	Name	City	State
France	Hôpital Beaujon	Clichy

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Sanofi-Synthelabo

Country where clinical trial is conducted

France, 

References & Publications (1)

Mantz J, Samama CM, Tubach F, Devereaux PJ, Collet JP, Albaladejo P, Cholley B, Nizard R, Barré J, Piriou V, Poirier N, Mignon A, Schlumberger S, Longrois D, Aubrun F, Farèse ME, Ravaud P, Steg PG; Stratagem Study Group. Impact of preoperative maintenance — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consisting of major thromboembolic events listed in the following table with their respective weights.	The score allocated to each patient is the weight of the event (zero if no event has occurred). For the patients having experienced more than one event, the score attributed is the "heaviest" weight among the events he has undergone.	A composite criterion measured at Day 30	Yes