Pathophysiology and Prevention of Perioperative Myocardial Injury: A Prospective Randomized Controlled Trial

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Giora Landesberg, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01810796
First received: March 12, 2013
Last updated: March 13, 2013
Last verified: March 2013

March 12, 2013
March 13, 2013
December 2013
December 2016   (final data collection date for primary outcome measure)
Postoperative troponin [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01810796 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pathophysiology and Prevention of Perioperative Myocardial Injury: A Prospective Randomized Controlled Trial
Pathophysiology and Prevention of Perioperative Myocardial Injury: A Prospective Randomized Controlled Trial

Working hypothesis and aims: 1) To explore the pathophysiology of postoperative troponin elevations and 2) whether ranolazine, a new anti-ischemic drug that has no effect on blood pressure or heart rate, prevents postoperative myocardial injury.

High-risk patients undergoing non cardiac surgery will be randomized to receive either Ranolazine or placebo perioperatively and troponin will be measured on the first 3 days after surgery.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Coronary Artery Disease,
Drug: Ranolazine
Ranolazine versus placebo
Other Name: Ranexa
  • Experimental: Ranolazine treatment
    Ranolazine 500-1000mg bid
    Intervention: Drug: Ranolazine
  • Placebo Comparator: Placebo
    Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
300
December 2017
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

- All patients age 18 and above, undergoing major surgery that require at least 24 hours (overnight) stay in the post anesthesia care unit (PACU) or intensive care unit (ICU), and who either have known history of CAD or at least 3 of the following Revised Cardiac Risk Index (RCRI) criteria29F17: 1) high-risk type of surgery, 2) history of ischemic heart disease, 3) history of congestive heart failure, 4) history of cerebrovascular disease, 5) diabetes mellitus, 6) renal failure (creatinine > 2mg/ml).

Exclusion Criteria:

  • Pregnancy, LV ejection fraction ≤35%, patients with severe valvular disease, patients with poor echocardiographic images, patients who cannot swallow the pill after surgery, refusal to participate
Both
18 Years and older
No
Contact: Giora Landesberg, Assoc. Prof. 97226777269 gio@cc.huji.ac.il
Israel
 
NCT01810796
HRanTrop
Yes
Giora Landesberg, Hadassah Medical Organization
Hadassah Medical Organization
Not Provided
Principal Investigator: Giora Landesberg, MD Hadassah Medical Organization
Hadassah Medical Organization
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP