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

This study has been completed.
Sponsor:
Collaborator:
Sanofi-Synthelabo
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00190307
First received: September 12, 2005
Last updated: September 20, 2011
Last verified: September 2005
  Purpose

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.


Condition Intervention Phase
Thrombosis
Drug: aspirin 75 mg/day
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: Strategy for Managing Antiplatelet Therapy in the Perioperative Period of Non Coronary Surgery

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Consisting of major thromboembolic events listed in the following table with their respective weights. [ Time Frame: A composite criterion measured at Day 30 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 293
Study Start Date: June 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Aspirin:KARDEGIC
Drug: aspirin 75 mg/day
aspirin 75 mg/day
Other Name: aspirin 75 mg/day

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190307

Locations
France
Hôpital Beaujon
Clichy, France, 92110
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Sanofi-Synthelabo
Investigators
Principal Investigator: Jean Mantz, MD Hôpital Beaujon, Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00190307     History of Changes
Other Study ID Numbers: P030440
Study First Received: September 12, 2005
Last Updated: September 20, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Long term antiplatelet therapy
Scheduled surgery

Additional relevant MeSH terms:
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 16, 2014