PeriOperative ISchemic Evaluation-2 Pilot (POISE2-pilot)

March 8, 2010 updated by: McMaster University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Walter C MacKenzie Health Sciences
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Hamilton Health Sciences
      • Hamilton, Ontario, Canada, L8N 4A6
        • St Joseph's Health Sciences
  • China
      • Hong Kong, China
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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
    • undergoing major vascular surgery (i.e., vascular surgery except arteriovenous shunt, vein stripping procedures, and carotid endarterectomies)

    • OR any 3 of 9 risk criteria:

      1. undergoing major surgery [i.e., intraperitoneal, intrathoracic, or orthopedic surgery]
      2. history of congestive heart failure
      3. transient ischemic attack
      4. diabetes and currently taking an oral hypoglycemic agent or insulin
      5. age = or > than 70 years
      6. hypertension
      7. serum creatinine > 175 µmol/L
      8. history of smoking within 2 years of surgery, or
      9. undergoing emergent/urgent surgery

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: active clonidine and active ASA
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.
Other Names:
  • CATAPRES, CATAPRES TTS
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.
Other Names:
  • ENTROPHEN CHEWABLE
EXPERIMENTAL: active clonidine and ASA placebo
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.
Other Names:
  • CATAPRES, CATAPRES TTS
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.
Other Names:
  • ENTROPHEN CHEWABLE placebo
EXPERIMENTAL: Clonidine placebo and active ASA
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.
Other Names:
  • ENTROPHEN CHEWABLE
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.
Other Names:
  • CATAPRES placebo and CATAPRES TTS placebo
PLACEBO_COMPARATOR: Clonidine placebo and ASA placebo
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.
Other Names:
  • ENTROPHEN CHEWABLE placebo
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.
Other Names:
  • CATAPRES placebo and CATAPRES TTS placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Feasibility of recruiting 90 patients in 6 months
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Feasibility of administering pre-operative ASA and clonidine
Time Frame: 6 months
6 months
Preliminary estimate of major bleeding and clinically significant hypotension
Time Frame: 30 days
30 days
Preliminary estimate of the composite of vascular death and non-fatal myocardial infarction.
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

The Physicians' Services Incorporated Foundation
Canadian Network and Centre for Trials Internationally

Investigators

  • Principal Investigator: P. J. Devereaux, MD FRCP PHD, McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

January 1, 2010

Study Registration Dates

First Submitted

March 12, 2009

First Submitted That Met QC Criteria

March 12, 2009

First Posted (ESTIMATE)

March 13, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 9, 2010

Last Update Submitted That Met QC Criteria

March 8, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POISE-2 01 2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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