PeriOperative ISchemic Evaluation-2 Pilot

NCT00860925 | Completed Phase 4

• 1 other identifier: POISE-2 01 2009
• Study Type: interventional
• Target: 90
• Locations: 2 countries
• Sites: 4

Brief 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. 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.

Conditions

Cardiovascular Disease

Keywords

Randomized Controlled Trial; Blinded; Clonidine; acetyl-salicylic acid (ASA); Perioperative vascular complications; Noncardiac surgery

Outcome Measures

Primary Outcomes (1)

• Feasibility of recruiting 90 patients in 6 months

  6 months

Secondary Outcomes (3)

• Feasibility of administering pre-operative ASA and clonidine

  6 months

• Preliminary estimate of major bleeding and clinically significant hypotension

  30 days

• Preliminary estimate of the composite of vascular death and non-fatal myocardial infarction.

  30 days

Study Arms (4)

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

Interventions

active clonidine DRUG

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.

Also known as: CATAPRES, CATAPRES TTS

active clonidine and ASA placebo; active clonidine and active ASA

active ASA DRUG

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.

Also known as: ENTROPHEN CHEWABLE

Clonidine placebo and active ASA; active clonidine and active ASA

Clonidine Placebo DRUG

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.

Also known as: CATAPRES placebo and CATAPRES TTS placebo

Clonidine placebo and ASA placebo; Clonidine placebo and active ASA

ASA Placebo DRUG

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.

Also known as: ENTROPHEN CHEWABLE placebo

Clonidine placebo and ASA placebo; active clonidine and ASA placebo

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• The Physicians' Services Incorporated Foundation: collaborator
• Canadian Network and Centre for Trials Internationally: collaborator

Study Sites (4)

Walter C MacKenzie Health Sciences

Edmonton, Alberta, T6G 2B7, Canada

Location

Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

Location

St Joseph's Health Sciences

Hamilton, Ontario, L8N 4A6, Canada

Location

Prince of Wales Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Clonidine

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• P. J. Devereaux, MD FRCP PHD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 12, 2009
• First Posted: March 13, 2009
• Study Start: May 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: January 1, 2010
• Last Updated: March 9, 2010

Record last verified: 2010-03

Locations

CA (3); CN (1)