Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00190307
Status:
COMPLETED
Last Update Posted:
2011-09-21
First Post:
2005-09-12
Brief Title:
STRATAGEM Strategy for Managing Antiplatelet Therapy in the Perioperative Period of Non Coronary Surgery
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Strategy for Managing Antiplatelet Therapy in the Perioperative Period of Non Coronary Surgery
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STRATAGEM
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 ie total mortality severe ischemic events ischemic stroke non-fatal myocardial infarction MI acute limb ischemia clinical deep venous thrombosis andor 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
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 ie total mortality severe ischemic events ischemic stroke non-fatal myocardial infarction MI acute limb ischemia clinical deep venous thrombosis andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None