Atherosclerotic DiseasePhase 3POISE-3NCT02546648
PeriOperative ISchemic Evaluation-3 Trial: A Pilot Study
A Phase 3 study testing Tranexamic Acid in people with Atherosclerotic Disease and Perioperative Bleeding, run by McMaster University at 2 sites in Canada.
Trial summary
A placebo-controlled, factorial trial to assess the impact of rosuvastatin and tranexamic acid (TXA) in patients undergoing noncardiac surgery who are at risk of a perioperative cardiovascular event. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Atherosclerotic Disease, Perioperative Bleeding
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesCanada
- Study dates
- Feb 2015to Aug 2016
- Phase
- Phase 3
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing noncardiac surgery
- >45 years of age
- expected to require at least an overnight hospital admission after surgery; AND
- have a preoperative NT-pro-BNP measurement >100 ng/mL; OR
- if a preoperative NT-pro-BNP measurement is not available, then the patient must fulfill 1 or more of the following 5 criteria:
- history of coronary artery disease
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- history of peripheral vascular disease
- history of stroke
- undergoing major vascular surgery
- have any 3 of the following 9 risk criteria:
- undergoing major surgery
- history of congestive heart failure
- history of a transient ischemic attack
- diabetic and currently taking an oral hypoglycemic agent or insulin
- age >70 years
- hypertension
- serum creatinine > 175 umol/L (>2.0 mg/dl)
- history of smoking within 2 years of surgery
- undergoing emergent/urgent surgery
Who cannot join
- planned use of systemic Tranexamic Acid during surgery
- hypersensitivity or known allergy to TXA
- creatinine clearance <30 mL/min (MDRD)
- history of seizure disorder
- history of venous thromboembolism
- acute arterial thrombosis
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- no preoperative measurement of hemoglobin
- subarachnoid hemorrhage within the past 30 days
- hematuria caused by diseases of the renal parenchyma
- previously enrolled in POISE-3 pilot trial
- not consenting to participate in POISE-3 pilot trial prior to surgery
- Patients meeting any of the following criteria will be excluded from the Rosuvastatin/Placebo arm:
- preoperative treatment with a statin or a non statin lipid lowering drug or ciclosporin during the 48 hours before surgery
- hypersensitivity or known allergy to Rosuvastatin
- pre-disposed factors for myopathy or rhabdomyolysis
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Juravinski Hospital
Hamilton, Ontario, L8V 1C3
About this study
Official title: PeriOperative ISchemic Evaluation-3 Trial: A Pilot Study (POISE-3)
A placebo-controlled, factorial trial to assess the impact of rosuvastatin and tranexamic acid (TXA) in patients undergoing noncardiac surgery who are at risk of a perioperative cardiovascular event.
Read the detailed description
The POISE-3 pilot is a randomized controlled trial of 100 patients with, or at risk of, atherosclerotic disease who are undergoing noncardiac surgery. Utilizing a partial factorial design, the POISE-3 pilot will determine the effect of rosuvastatin versus placebo and TXA versus placebo in the perioperative setting.
- Conditions
- Atherosclerotic Disease, Perioperative Bleeding
- Being tested
- Tranexamic Acid, Tranexamic Acid Placebo, Rosuvastatin or matching placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called Cyklokapron
Tranexamic Acid PlaceboDrug
Rosuvastatin or matching placeboDrug
Also called Crestor
Subjects who are not on a statin will also be randomized to Rosuvastatin or Rosuvastatin placebo. 40mg preoperatively, followed by 20mg postoperatively (4-6 hours after surgical close) and 20mg/day for 30 days postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid vs. matching placebo | Experimental | Tranexamic Acid 1g bolus with anesthesia induction followed by 1g bolus at the start of surgical closure. Receives: Drug: Tranexamic Acid; Drug: Tranexamic Acid Placebo |
| Rosuvastatin vs. matching placebo | Experimental | Rosuvastatin 20 mg orally or matching placebo once per day until 30 days after surgery Receives: Drug: Rosuvastatin or matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative intervention discontinuation
Interruption of the intervention longer than 24 hours within the first 10 days postoperatively, and longer than 48 hours from postoperative day 10 to 30.
Measured: Postoperative day 1 to 30.
Change in hemoglobin
Change in preoperative hemoglobin to the morning hemoglobin recorded on day 1 after surgery.
Measured: Postoperative day 1.
Secondary outcomes (3)
All-cause mortality
Measured: Postoperative day 30.
Non-fatal myocardial infarction
Measured: Postoperative day 30.
A composite of vascular mortality and non-fatal: myocardial infarction, stroke, cardiac arrest, pulmonary embolus, deep venous thrombosis, life threatening bleeding, major bleeding.
Event composite
Measured: Postoperative day 30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startFeb 2015
- Primary completionOct 2015
- Study completionAug 2016
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 Atherosclerotic DiseaseStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Population Health Research Institute, Hamilton Health Sciences Corporation
- Responsible party
- Sponsor
- Investigators
- James Khan, MD, Study chair, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546648
- Sponsor's protocol ID
- POISE3034
- Acronym
- POISE-3
- Status last verified
- Aug 2017
- First submitted
- 9 Sep 2015
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Marcucci M, Duceppe E, Le Manach Y, Kearon C, Eikelboom JW, Pohl K, Vincent J, Darvish-Kazem S, Srinathan SK, Neary JDD, Parlow JL, Kurz A, Gross PL, Mrkobrada M, Balasubramanian K, Sessler DI, Devereaux PJ. Tranexamic acid and rosuvastatin in patients at risk of cardiovascular events after noncardiac surgery: a pilot of the POISE-3 randomized controlled trial. Pilot Feasibility Stud. 2020 Jul 21;6:104. doi: 10.1186/s40814-020-00643-9. eCollection 2020.
PubMed 32699643
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PeriOperative ISchemic Evaluation-3 Trial: A Pilot Study (POISE-3)
- ClinicalTrials.gov ID
- NCT02546648
- Acronym / sponsor ID
- POISE-3 / POISE3034
- Conditions
- Atherosclerotic Disease, Perioperative Bleeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Population Health Research Institute, Hamilton Health Sciences Corporation
- Study start
- Feb 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 11 Sep 2015 (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.
A placebo-controlled, factorial trial to assess the impact of rosuvastatin and tranexamic acid (TXA) in patients undergoing noncardiac surgery who are at risk of a perioperative cardiovascular event.
Detailed description
The POISE-3 pilot is a randomized controlled trial of 100 patients with, or at risk of, atherosclerotic disease who are undergoing noncardiac surgery. Utilizing a partial factorial design, the POISE-3 pilot will determine the effect of rosuvastatin versus placebo and TXA versus placebo in the perioperative setting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid vs. matching placebo | Experimental | Drug: Tranexamic Acid, Drug: Tranexamic Acid PlaceboTranexamic Acid 1g bolus with anesthesia induction followed by 1g bolus at the start of surgical closure. |
| Rosuvastatin vs. matching placebo | Experimental | Drug: Rosuvastatin or matching placeboRosuvastatin 20 mg orally or matching placebo once per day until 30 days after surgery |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- undergoing noncardiac surgery
- >45 years of age
- expected to require at least an overnight hospital admission after surgery; AND
- have a preoperative NT-pro-BNP measurement >100 ng/mL; OR
- if a preoperative NT-pro-BNP measurement is not available, then the patient must fulfill 1 or more of the following 5 criteria:
Key exclusion criteria (15 listed)
- planned use of systemic Tranexamic Acid during surgery
- hypersensitivity or known allergy to TXA
- creatinine clearance <30 mL/min (MDRD)
- history of seizure disorder
- history of venous thromboembolism
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 |
|---|---|---|
| Tranexamic AcidAlso: Cyklokapron | Drug | Tranexamic Acid vs. matching placebo |
| Tranexamic Acid Placebo | Drug | Tranexamic Acid vs. matching placebo |
| Rosuvastatin or matching placeboAlso: CrestorSubjects who are not on a statin will also be randomized to Rosuvastatin or Rosuvastatin placebo. 40mg preoperatively, followed by 20mg postoperatively (4-6 hours after surgical close) and 20mg/day for 30 days postoperatively. | Drug | Rosuvastatin vs. matching placebo |
Primary outcome
Postoperative intervention discontinuation
Time frame: Postoperative day 1 to 30.
Interruption of the intervention longer than 24 hours within the first 10 days postoperatively, and longer than 48 hours from postoperative day 10 to 30.
Change in hemoglobin
Time frame: Postoperative day 1.
Change in preoperative hemoglobin to the morning hemoglobin recorded on day 1 after surgery.
3 secondary outcomes
All-cause mortality
Time frame: Postoperative day 30.
Non-fatal myocardial infarction
Time frame: Postoperative day 30.
A composite of vascular mortality and non-fatal: myocardial infarction, stroke, cardiac arrest, pulmonary embolus, deep venous thrombosis, life threatening bleeding, major bleeding.
Time frame: Postoperative day 30.
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 24 Apr 2018.
- Derived from this study: PubMed 32699643Marcucci M, Duceppe E, Le Manach Y, Kearon C, Eikelboom JW, Pohl K, Vincent J, Darvish-Kazem S, Srinathan SK, Neary JDD, Parlow JL, Kurz A, Gross PL, Mrkobrada M, Balasubramanian K, Sessler DI, Devereaux PJ. Tranexamic acid and rosuvastatin in patients at risk of cardiovascular events after noncardiac surgery: a pilot of the POISE-3 randomized controlled trial. Pilot Feasibility Stud. 2020 Jul 21;6:104. doi: 10.1186/s40814-020-00643-9. eCollection 2020.
- Individual participant dataSharing planned: No
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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.
James Khan, MD study chair
Hamilton Health Sciences Corporation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tranexamic Acid in people with Atherosclerotic Disease and Perioperative Bleeding, run by McMaster University at 2 sites in Canada.
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 19 inclusion and 15 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 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Postoperative intervention discontinuation (time frame: Postoperative day 1 to 30.). The study lists 2 primary outcomes in all. 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 NCT02546648, 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 24 Apr 2018.