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

Completed

Phase 4 Results N/A

Trial Description

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.

Conditions

Interventions

  • Aspirin (stroke prevention) Drug
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
  • Aspirin 75 mg/day Drug
    Other Names: aspirin 75 mg/day
    Intervention Desc: aspirin 75 mg/day
    ARM 1: Kind: Experimental
    Label: 1
    Description: Aspirin:KARDEGIC

Trial Design

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

Patient Involvement

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.

Outcomes

Type Measure Time Frame Safety Issue
Primary Composite endpoint of thrombotic and hemorragic events, measured 30 days after surgery, reflecting the net clinical benefit of each strategy (discontinuation of antiplatelet agents vs low-dose aspirin). All cause mortality: non-fatal myocardial infarction; documented stroke/transient ischemic attack; lower limb critical ischemia; clinical deep venous thrombosis; major bleeding; intracerebral hemorrhage; hemorrhage resulting in redo surgery or endoscopic sclerosis; transfusions of more than 2 units of packed red blood cells; intra- or retroperitoneal bleeding.
Secondary Individual components of the composite endpoint; all bleeding complications, fatal or non-fatal.
Primary Consisting of major thromboembolic events listed in the following table with their respective weights. A composite criterion measured at Day 30 Yes

Sponsors