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Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery

NCT01352416 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-01-06

Study results available
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Summary

The objective of this study is to show that ranolazine is a safe, viable and potent alternative for post-operative atrial fibrillation suppression in patients undergoing cardiac surgery

Conditions

  • Heart; Dysfunction Postoperative, Cardiac Surgery

Interventions

DRUG

Ranolazine

Ranolazine 1000mg (2-500mg tablets) twice daily. Starting 2 days prior to surgery, morning of surgery and up to 14 days post operative depending when the breathing tube is removed from the patient post operative. If intolerant to the study drug due to adverse effects or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500mg (1-500mg tablet) twice daily

DRUG

Placebo

Placebo 1000mg (2-500mg tablets) twice daily. Starting 2 days prior to surgery, morning of surgery and up to 14 days post operative depending when the breathing tube is removed from the patient post operative. If intolerant to the study drug due to adverse effects or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500mg (1-500mg tablet) twice daily

Sponsors & Collaborators

  • Beaumont Foundation of America

    collaborator OTHER

  • Gilead Sciences

    collaborator INDUSTRY

  • William Beaumont Hospitals

    lead OTHER

Principal Investigators

  • Ilana Kutinsky, DO · William Beaumont Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01352416 on ClinicalTrials.gov