Cardiovascular DiseasePhase 4POISE2-pilotNCT00860925
PeriOperative ISchemic Evaluation-2 Pilot
A Phase 4 study testing active clonidine and active ASA in people with Cardiovascular Disease, run by McMaster University at 4 sites in 2 countries.
Trial summary
Major non-cardiac surgeries are common and major heart problems during or after such surgeries represent a large population health problem. Few treatments to prevent heart problems around the time of surgery have been tested. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- active clonidine and active ASA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 4 sitesin 2 countries
- Study dates
- May 2009to Jan 2010
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing noncardiac surgery who fulfill the following criteria:
- age ≥ 45 years
- expected to require at least an overnight hospital admission after noncardiac surgery, and fulfill any 1 of the following criteria:
- history of coronary artery disease
- peripheral vascular disease
- stroke
Show all 17Show fewer
- undergoing major vascular surgery (i.e., vascular surgery except arteriovenous shunt, vein stripping procedures, and carotid endarterectomies)
- OR any 3 of 9 risk criteria:
- undergoing major surgery [i.e., intraperitoneal, intrathoracic, or orthopedic surgery]
- history of congestive heart failure
- transient ischemic attack
- diabetes and currently taking an oral hypoglycemic agent or insulin
- age = or > than 70 years
- hypertension
- serum creatinine > 175 µmol/L
- history of smoking within 2 years of surgery, or
- undergoing emergent/urgent surgery
Who cannot join
- Patients has taken ASA < or = to 72 hours before scheduled surgery
- history of ASA or clonidine hypersensitivity or allergy
- systolic blood pressure < 105 mm Hg
- heart rate < 55 beats per minute
- second or third degree heart block without a pacemaker
- patient has active peptic ulcer disease
Show all 13Show fewer
- Patient has had a bare metal stent in the six weeks prior to randomization
- Patient has had a drug eluting stent in the year prior to randomization
- Patient is currently taking an alpha-2 agonist, alpha methyldopa, reserpine, clopidogrel, or ticlopidine
- Patient undergoing intracranial surgery, carotid endarterectomy, or retinal surgery
- Surgeon unwilling to have patient participate in a participate in a perioperative clonidine/ASA trial
- Prior enrolment in the POISE-2 pilot trial
- Unable to obtain or refusal to consent prior to surgery
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Canada3 sites
Walter C MacKenzie Health Sciences
Edmonton, Alberta, T6G 2B7
Hamilton Health Sciences
Hamilton, Ontario, L8N 3Z5
St Joseph's Health Sciences
Hamilton, Ontario, L8N 4A6
About this study
Official title: PeriOperative ISchemic Evaluation-2 (POISE-2) Trial: A Pilot
Major non-cardiac surgeries are common and major heart problems during or after such surgeries represent a large population health problem. Few treatments to prevent heart problems around the time of surgery have been tested.
There is encouraging data suggesting that low-doses of Acetyl-Salicylic Acid (ASA) and Clonidine, which are two medications, given individually for a short period before and after major surgeries may prevent major heart problems.
Read the detailed description
The POISE-2 Pilot Trial will provide the essential remaining feasibility data that POISE-2 researchers require prior to conducting a large international study to test the effect of ASA and Clonidine in preventing major vascular complications during the first 30 days after surgery.
The POISE-2 Pilot Trial is a factorial design randomized control trial that will compare ASA to placebo and clonidine to placebo. Patients in the POISE-2 pilot trial will be randomly assigned to one of four groups: ASA and Clonidine together, ASA and Clonidine placebo, ASA placebo and Clonidine, or a ASA placebo and Clonidine placebo. Two to four hours prior to surgery, eligible patients are given ASA study drug and Clonidine study drug orally (162mg ASA or its placebo and 0.2mg Clonidine or its placebo) and a patch to apply (0.2mg/day Clonidine or its placebo). The patch will remain in place for 72 hours after surgery. After the surgery, patients ingest one tablet a day (81mg ASA or its placebo) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery. Troponin measurements will be collected between 6 to 12 hours after the operation and on the 1st, 2nd, and 3rd days after surgery. If blood tests reveal an elevation in the troponin measurement an electrocardiogram (ECG) will be undertaken immediately.
Research personnel will follow patients until 30 days after surgery.
- Conditions
- Cardiovascular Disease
- Being tested
- active clonidine, active ASA, Clonidine Placebo, ASA Placebo
- Keywords
- Randomized Controlled Trial, Blinded, Clonidine, acetyl-salicylic acid (ASA), Perioperative vascular complications, Noncardiac surgery
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active clonidineDrug
Also called CATAPRES, CATAPRES TTS
Prior to surgery (goal 2-4 hours) patients will ingest 1 tablet of clonidine (0.2 mg) and will have a transdermal clonidine patch (0.2 mg/day) applied. The patch will be removed at 72 hours after surgery.
active ASADrug
Also called ENTROPHEN CHEWABLE
Prior to surgery (goal 2-4 hours) patients will ingest 2 ASA tablets (81 mg per tablet). After the first dose, patients will ingest 1 tablet daily for 7 or 30 days according to the stratum they are allocated to. Patients who are not able to take ASA orally will receive it rectally.
Clonidine PlaceboDrug
Also called CATAPRES placebo and CATAPRES TTS placebo
Prior to surgery (goal 2-4 hours) patients will take oral clonidine placebo and will have a transdermal placebo patch applied. The patch will be removed at 72 hours after surgery.
ASA PlaceboDrug
Also called ENTROPHEN CHEWABLE placebo
Prior to surgery (goal 2-4 hours) patients will ingest 2 ASA placebo tablets. After the first dose, patients will ingest 1 placebo tablet daily for 7 or 30 days according to the stratum they are allocated to. Patients who are not able to take placebo orally will receive it rectally.
| Study group | Role | What they receive |
|---|---|---|
| active clonidine and active ASA | Experimental | Not described Receives: Drug: active clonidine; Drug: active ASA |
| active clonidine and ASA placebo | Experimental | Not described Receives: Drug: active clonidine; Drug: ASA Placebo |
| Clonidine placebo and active ASA | Experimental | Not described Receives: Drug: active ASA; Drug: Clonidine Placebo |
| Clonidine placebo and ASA placebo | Placebo comparator | Not described Receives: Drug: Clonidine Placebo; Drug: ASA Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruiting 90 patients in 6 months
Measured: 6 months
Secondary outcomes (3)
Feasibility of administering pre-operative ASA and clonidine
Measured: 6 months
Preliminary estimate of major bleeding and clinically significant hypotension
Measured: 30 days
Preliminary estimate of the composite of vascular death and non-fatal myocardial infarction.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation, Canadian Network and Centre for Trials Internationally
- Investigators
- P. J. Devereaux, MD FRCP PHD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860925
- Sponsor's protocol ID
- POISE-2 01 2009
- Acronym
- POISE2-pilot
- Status last verified
- Mar 2010
- First submitted
- 12 Mar 2009
- Last updated
- 9 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PeriOperative ISchemic Evaluation-2 (POISE-2) Trial: A Pilot
- ClinicalTrials.gov ID
- NCT00860925
- Acronym / sponsor ID
- POISE2-pilot / POISE-2 01 2009
- Conditions
- Cardiovascular Disease
- Keywords
- Randomized Controlled Trial, Blinded, Clonidine, acetyl-salicylic acid (ASA), Perioperative vascular complications, Noncardiac surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation, Canadian Network and Centre for Trials Internationally
- Study start
- May 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 13 Mar 2009 (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.
Major non-cardiac surgeries are common and major heart problems during or after such surgeries represent a large population health problem. Few treatments to prevent heart problems around the time of surgery have been tested.
There is encouraging data suggesting that low-doses of Acetyl-Salicylic Acid (ASA) and Clonidine, which are two medications, given individually for a short period before and after major surgeries may prevent major heart problems.
Detailed description
The POISE-2 Pilot Trial will provide the essential remaining feasibility data that POISE-2 researchers require prior to conducting a large international study to test the effect of ASA and Clonidine in preventing major vascular complications during the first 30 days after surgery.
The POISE-2 Pilot Trial is a factorial design randomized control trial that will compare ASA to placebo and clonidine to placebo. Patients in the POISE-2 pilot trial will be randomly assigned to one of four groups: ASA and Clonidine together, ASA and Clonidine placebo, ASA placebo and Clonidine, or a ASA placebo and Clonidine placebo. Two to four hours prior to surgery, eligible patients are given ASA study drug and Clonidine study drug orally (162mg ASA or its placebo and 0.2mg Clonidine or its placebo) and a patch to apply (0.2mg/day Clonidine or its placebo). The patch will remain in place for 72 hours after surgery. After the surgery, patients ingest one tablet a day (81mg ASA or its placebo) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery. Troponin measurements will be collected between 6 to 12 hours after the operation and on the 1st, 2nd, and 3rd days after surgery. If blood tests reveal an elevation in the troponin measurement an electrocardiogram (ECG) will be undertaken immediately.
Research personnel will follow patients until 30 days after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| active clonidine and active ASA | Experimental | Drug: active clonidine, Drug: active ASA |
| active clonidine and ASA placebo | Experimental | Drug: active clonidine, Drug: ASA Placebo |
| Clonidine placebo and active ASA | Experimental | Drug: active ASA, Drug: Clonidine Placebo |
| Clonidine placebo and ASA placebo | Placebo comparator | Drug: Clonidine Placebo, Drug: ASA Placebo |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- age ≥ 45 years
- expected to require at least an overnight hospital admission after noncardiac surgery, and fulfill any 1 of the following criteria:
Key exclusion criteria (13 listed)
- Patients has taken ASA < or = to 72 hours before scheduled surgery
- history of ASA or clonidine hypersensitivity or allergy
- systolic blood pressure < 105 mm Hg
- heart rate < 55 beats per minute
- second or third degree heart block without a pacemaker
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 |
|---|---|---|
| active clonidineAlso: CATAPRES, CATAPRES TTSPrior to surgery (goal 2-4 hours) patients will ingest 1 tablet of clonidine (0.2 mg) and will have a transdermal clonidine patch (0.2 mg/day) applied. The patch will be removed at 72 hours after surgery. | Drug | active clonidine and ASA placebo, active clonidine and active ASA |
| active ASAAlso: ENTROPHEN CHEWABLEPrior to surgery (goal 2-4 hours) patients will ingest 2 ASA tablets (81 mg per tablet). After the first dose, patients will ingest 1 tablet daily for 7 or 30 days according to the stratum they are allocated to. Patients who are not able to take ASA orally will receive it rectally. | Drug | Clonidine placebo and active ASA, active clonidine and active ASA |
| Clonidine PlaceboAlso: CATAPRES placebo and CATAPRES TTS placeboPrior to surgery (goal 2-4 hours) patients will take oral clonidine placebo and will have a transdermal placebo patch applied. The patch will be removed at 72 hours after surgery. | Drug | Clonidine placebo and ASA placebo, Clonidine placebo and active ASA |
| ASA PlaceboAlso: ENTROPHEN CHEWABLE placeboPrior to surgery (goal 2-4 hours) patients will ingest 2 ASA placebo tablets. After the first dose, patients will ingest 1 placebo tablet daily for 7 or 30 days according to the stratum they are allocated to. Patients who are not able to take placebo orally will receive it rectally. | Drug | Clonidine placebo and ASA placebo, active clonidine and ASA placebo |
Primary outcome
Feasibility of recruiting 90 patients in 6 months
Time frame: 6 months
3 secondary outcomes
Feasibility of administering pre-operative ASA and clonidine
Time frame: 6 months
Preliminary estimate of major bleeding and clinically significant hypotension
Time frame: 30 days
Preliminary estimate of the composite of vascular death and non-fatal myocardial infarction.
Time frame: 30 days
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 9 Mar 2010.
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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.
P. J. Devereaux, MD FRCP PHD principal investigator
McMaster University
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing active clonidine and active ASA in people with Cardiovascular Disease, run by McMaster University at 4 sites in 2 countries.
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 17 inclusion and 13 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 9 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada, China. 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. Some participants in this study may receive a placebo. 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?
Feasibility of recruiting 90 patients in 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2010.