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Sponsors and Collaborators: |
McMaster University The Physicians' Services Incorporated Foundation Canadian Network and Centre for Trials Internationally |
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Information provided by: | McMaster University |
ClinicalTrials.gov Identifier: | NCT00860925 |
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.
Condition | Intervention | Phase |
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Cardiovascular Disease |
Drug: active clonidine Drug: active ASA Drug: Clonidine Placebo Drug: ASA Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment |
Official Title: | PeriOperative ISchemic Evaluation-2 (POISE-2) Trial: A Pilot |
Estimated Enrollment: | 90 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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active clonidine and active ASA: Experimental |
Drug: active clonidine
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.
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.
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active clonidine and ASA placebo: Experimental |
Drug: active clonidine
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.
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.
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Clonidine placebo and active ASA: Experimental |
Drug: active ASA
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.
Drug: Clonidine 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.
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Clonidine placebo and ASA placebo: Placebo Comparator |
Drug: Clonidine 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.
Drug: ASA 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.
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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.
Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients undergoing noncardiac surgery who fulfill the following criteria:
expected to require at least an overnight hospital admission after noncardiac surgery, and fulfill any 1 of the following criteria:
OR any 3 of 9 risk criteria:
Exclusion Criteria:
Contact: Susan Haley, BSc | 905 525-9140 ext 22941 | haleys@mcmaster.ca |
Contact: Shirley Pettit, BSc RN | 905 522-1155 ext 33092 | pettits@mcmaster.ca |
Canada, Alberta | |
Walter C MacKenzie Health Sciences | |
Edmonton, Alberta, Canada, T6G 2B7 | |
Canada, Ontario | |
Hamilton Health Sciences | |
Hamilton, Ontario, Canada, L8N 3Z5 | |
St Joseph's Health Sciences | |
Hamilton, Ontario, Canada, L8N 4A6 | |
China | |
Prince of Wales Hospital | |
Hong Kong, China |
Principal Investigator: | P. J. Devereaux, MD FRCP PHD | McMaster University |
Responsible Party: | McMaster University ( Dr P.J. Devereaux ) |
Study ID Numbers: | POISE-2 01 2009 |
Study First Received: | March 12, 2009 |
Last Updated: | April 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00860925 History of Changes |
Health Authority: | Canada: Health Canada |
Randomized Controlled Trial Blinded Clonidine |
acetyl-salicylic acid (ASA) Perioperative vascular complications Noncardiac surgery |
Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic Agents Aspirin Clonidine Salicylic Acid |
Cardiovascular Agents Peripheral Nervous System Agents Analgesics Ischemia Antihypertensive Agents Adrenergic Agonists |
Sympatholytics Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Clonidine Physiological Effects of Drugs Cardiovascular Agents Antihypertensive Agents |
Adrenergic Agonists Pharmacologic Actions Autonomic Agents Sensory System Agents Therapeutic Uses Cardiovascular Diseases Analgesics Peripheral Nervous System Agents Central Nervous System Agents |