ThrombosisPhase 4STRATAGEMNCT00190307
STRATAGEM: Strategy for Managing Antiplatelet Therapy in the Perioperative Period of Non Coronary Surgery
A Phase 4 study testing aspirin 75 mg/day in people with Thrombosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombosis
- What is being tested?
- aspirin 75 mg/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 293 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2005to Dec 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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
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- Ophthalmological surgery (posterior chamber)
- Neurosurgery
- Emergency surgery
- Thrombotic or bleeding risk deemed unacceptable by the surgical and anesthetic team
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strategy for Managing Antiplatelet Therapy in the Perioperative Period of Non Coronary Surgery
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.
Read the 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
- Thrombosis
- Being tested
- aspirin 75 mg/day
- Keywords
- Long term antiplatelet therapy, Scheduled surgery
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirin 75 mg/dayDrug
aspirin 75 mg/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Aspirin:KARDEGIC Receives: Drug: aspirin 75 mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: A composite criterion measured at Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi-Synthelabo
- Responsible party
- Sponsor
- Investigators
- Jean Mantz, MD, Principal investigator, Hôpital Beaujon, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00190307
- Sponsor's protocol ID
- P030440
- Acronym
- STRATAGEM
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 21 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21873632
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategy for Managing Antiplatelet Therapy in the Perioperative Period of Non Coronary Surgery
- ClinicalTrials.gov ID
- NCT00190307
- Acronym / sponsor ID
- STRATAGEM / P030440
- Conditions
- Thrombosis
- Keywords
- Long term antiplatelet therapy, Scheduled surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Sanofi-Synthelabo
- Study start
- Jun 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: aspirin 75 mg/dayAspirin:KARDEGIC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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):
- Patients scheduled for intermediate or high-risk surgery, including but not limited to:
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aspirin 75 mg/dayaspirin 75 mg/day | Drug | 1 |
Primary outcome
Consisting of major thromboembolic events listed in the following table with their respective weights.
Time frame: A composite criterion measured at Day 30
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2011.
- Results publication: PubMed 21873632Mantz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Mantz, MD principal investigator
Hôpital Beaujon, Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing aspirin 75 mg/day in people with Thrombosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consisting of major thromboembolic events listed in the following table with their respective weights. (time frame: A composite criterion measured at Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00190307, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2011.