Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery

NCT01352416 | Terminated Phase 3 Results DMC

• 1 other identifier: 2009-101, IN-US-259-0114
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Suppress Atrial Fibrillation; heart bypass surgery; heart valve surgery

Outcome Measures

Primary Outcomes (1)

• Freedom From Any Episode of Post Operative Atrial Fibrillation Longer Than 6 Hours Duration Occurring During the Study Period.

  Freedom from any episode of post operative Atrial Fibrillation (AF) longer than 6 hours duration occurring during the study period. To document post operative atrial fibrillation.

  The time between the completion of the operation and hospital discharge or 14 days post operative if the hospitalzation is prolonged

Study Arms (4)

CABG surgery with Ranolazine

ACTIVE COMPARATOR

Patient will undergo Coronary Artery Bypass Graft (open heart surgery) and will receive, Ranolazine 1000 mg (2-500mg tablets) twice daily. 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 500 mg (1-500mg tablet) twice daily.

Drug: Ranolazine

CABG surgery with placebo

PLACEBO COMPARATOR

Patient will undergo Coronary Artery Bypass Graft (open heart surgery) and will receive, Placebo 1000mg mg (2-500mg tablets)twice daily. 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

Heart Valve surgery with Ranolazine

ACTIVE COMPARATOR

Patient will undergo heart Valve surgery and will receive, Ranolazine1000mg (2-500 mg tablets) twice a day. 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 500 mg (1-500mg tablet) twice a day.

Drug: Ranolazine

Heart Valve surgery with placebo

PLACEBO COMPARATOR

Patient will undergo heart Valve surgery and will receive, Placebo 1000mg (2-500mg tablets) twice a day. 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 a day.

Drug: Placebo

Interventions

Ranolazine DRUG

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

Also known as: Ranexa

CABG surgery with Ranolazine; Heart Valve surgery with Ranolazine

Placebo DRUG

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

Also known as: inactive ingredients pill

CABG surgery with placebo; Heart Valve surgery with placebo

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indications for cardiac surgery (CABG, valve surgery or CABG and valve surgery, Able to provide informed consent.

You may not qualify if:

• Documented atrial fibrillation within the previous 3 months
• Ongoing therapy with suppressive antiarrhythmic drugs
• Patient currently on digoxin
• Emergent surgery
• Patient receiving hemodialysis
• Concomitant use of ketoconazole, diltiazem, verapamil
• Known tolerance or hypersensitivity to ranolazine
• Pregnant individuals
• MAZE procedure (is a surgical ablation to treat atrial fibrillation) performed during concurrent cardiac surgery

Sponsors & Collaborators

• Corewell Health East: lead
• Beaumont Foundation of America: collaborator
• Gilead Sciences: collaborator

Study Sites (2)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

William Beaumont Hospital

Troy, Michigan, 48085-1198, United States

Location

MeSH Terms

Interventions

Ranolazine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Early termination due to lack of enrollment. 15 pts enrolled, 6 withdrawn due breathing tube not removed by 10 pm day of surgery. 1 withdrawn after day 3 as he was in afib and placed on amio. All pts were male.

Results Point of Contact

• Title: Ilana Kutinsky, DO
• Organization: William Beaumont Hospital

ikutinsky@beaumont.edu

248-267-5050

Study Officials

• Ilana Kutinsky, DO

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: May 4, 2011
• First Posted: May 11, 2011
• Study Start: September 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 6, 2017
• Results First Posted: January 6, 2017

Record last verified: 2016-11

Locations

US (2)