NCT00998218

Brief Summary

The purpose this investigation is to more thoroughly investigate the effects of ranolazine on arrhythmias and microvolt t-wave alternans in patients who have an automatic implantable cardioverter defibrillator (AICD) implanted either prophylactically to prevent sudden cardiac death, as well as in patients who may have had a clinically significant arrhythmic event prompting the insertion of the automatic implantable cardioverter defibrillator. It is anticipated this study will provide valuable new insight into the potential use of ranolazine to treat arrhythmias in higher risk patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 20, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 9, 2012

Status Verified

February 1, 2012

Enrollment Period

1.2 years

First QC Date

October 16, 2009

Last Update Submit

February 8, 2012

Conditions

Sudden Cardiac DeathVentricular Arrythmias

Keywords

Sudden Cardiac DeathArrythmiasTriggered activityleft ventricular dysfunction

Outcome Measures

Primary Outcomes (1)

  • The effect of ranolazine compared to placebo on MVTWA and reproducibility of MVTWA will be demonstrated. A p value of < 0.05 will be considered significant

    After 4 weeks of treatment

Study Arms (2)

Ranolazine

EXPERIMENTAL

Ranolazine at 1000 mg BID (or 500 mg BID if the 1000 mg dose was not tolerated) for 4 weeks

Drug: Ranolazine

Sugar pill

PLACEBO COMPARATOR

Placebo comparator BID for 4 weeks.

Drug: Placebo

Interventions

RanolazineDRUG

Ranolazine at 1000 mg BID (or 500 mg BID if the 1000 mg dose was not tolerated) or a comparable placebo for the next 4 weeks

Ranolazine
PlaceboDRUG

Ranolazine at 1000 mg BID (or 500 mg BID if the 1000 mg dose was not tolerated) or a comparable placebo for the next 4 weeks

Sugar pill

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Implant of AICD for the prevention of sudden cardiac death Implant of AICD for the prevention of sudden cardiac death

You may not qualify if:

  • Any anti-arrhythmic agent (other than beta-blockers)
  • History of or intolerance to ranolazine during the run in.
  • History of severe constipation defined as requiring laxatives more than 5 times a week in order to have a bowel movement.
  • Because of a weak inhibitory effect of ranolazine of the cytochrome p450, CYP 3A4, certain drugs metabolized by that system could accumulate. Although clinically significant interactions of ranolazine with these agents has not been demonstrated, patients on maximum doses of simvastatin, or patients on verapamil or diltiazem will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aspirus Wausau Hospital

Wausau, Wisconsin, 54401, United States

Location

Related Publications (3)

  • Tomaselli GF, Zipes DP. What causes sudden death in heart failure? Circ Res. 2004 Oct 15;95(8):754-63. doi: 10.1161/01.RES.0000145047.14691.db.

    PMID: 15486322BACKGROUND

  • Ebinger MW, Krishnan S, Schuger CD. Mechanisms of ventricular arrhythmias in heart failure. Curr Heart Fail Rep. 2005 Sep;2(3):111-7. doi: 10.1007/s11897-005-0018-y.

    PMID: 16138946BACKGROUND

  • Antzelevitch C, Belardinelli L, Zygmunt AC, Burashnikov A, Di Diego JM, Fish JM, Cordeiro JM, Thomas G. Electrophysiological effects of ranolazine, a novel antianginal agent with antiarrhythmic properties. Circulation. 2004 Aug 24;110(8):904-10. doi: 10.1161/01.CIR.0000139333.83620.5D. Epub 2004 Aug 9.

    PMID: 15302796BACKGROUND

MeSH Terms

Conditions

Death, Sudden, CardiacVentricular Dysfunction, Left

Interventions

Ranolazine

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and SymptomsVentricular Dysfunction

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • David K. Murdock, MD

    Aspirus Heart and Vascular Institute-Research and Education

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 16, 2009

First Posted

October 20, 2009

Study Start

September 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

February 9, 2012

Record last verified: 2012-02

Locations

US(1)