PeriOperative ISchemic Evaluation-2 Pilot - Full Text View

Sponsor:	McMaster University
Collaborators:	The Physicians' Services Incorporated Foundation Canadian Network and Centre for Trials Internationally
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00860925

Purpose

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
Cardiovascular Disease	Drug: active clonidine Drug: active ASA Drug: Clonidine Placebo Drug: ASA Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	PeriOperative ISchemic Evaluation-2 (POISE-2) Trial: A Pilot

Resource links provided by NLM:

Drug Information available for: Clonidine Clonidine hydrochloride

U.S. FDA Resources

Further study details as provided by McMaster University:

Primary Outcome Measures:

Feasibility of recruiting 90 patients in 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Feasibility of administering pre-operative ASA and clonidine [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Preliminary estimate of major bleeding and clinically significant hypotension [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Preliminary estimate of the composite of vascular death and non-fatal myocardial infarction. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment:	90
Study Start Date:	May 2009
Study Completion Date:	January 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: CATAPRES placebo and CATAPRES TTS placebo
Placebo Comparator: Clonidine placebo and ASA 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 Name: CATAPRES placebo and CATAPRES TTS 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 Name: ENTROPHEN CHEWABLE placebo

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.

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860925

Locations

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

Sponsors and Collaborators

McMaster University

The Physicians' Services Incorporated Foundation

Canadian Network and Centre for Trials Internationally

Investigators

Principal Investigator:

P. J. Devereaux, MD FRCP PHD

McMaster University

More Information

No publications provided

Responsible Party:	Dr P.J. Devereaux, McMaster University
ClinicalTrials.gov Identifier:	NCT00860925 History of Changes
Other Study ID Numbers:	POISE-2 01 2009
Study First Received:	March 12, 2009
Last Updated:	March 8, 2010
Health Authority:	Canada: Health Canada

Keywords provided by McMaster University:

Randomized Controlled Trial
Blinded
Clonidine

acetyl-salicylic acid (ASA)
Perioperative vascular complications
Noncardiac surgery

Additional relevant MeSH terms:

Cardiovascular Diseases
Clonidine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012