Ranolazine Cardioprotection in PCI
This study is currently recruiting participants.
Verified May 2013 by Kettering Health Network
Sponsor:
Harvey Hahn
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Harvey Hahn, Kettering Health Network
ClinicalTrials.gov Identifier:
NCT01767987
First received: November 28, 2012
Last updated: May 2, 2013
Last verified: May 2013
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Purpose
The investigators will test if upfront dosing of Ranolazine can reduce myocardial biomarker release (CK-MB, Troponin) post percutaneous coronary intervention (PCI).
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Coronary Syndrome |
Drug: Ranolazine Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| Official Title: | Ranolazine Cardioprotection in PCI |
Resource links provided by NLM:
Further study details as provided by Kettering Health Network:
Primary Outcome Measures:
- Troponin [ Time Frame: 8-10 hrs post PCI ] [ Designated as safety issue: No ]Troponin labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first
- CK-MB [ Time Frame: 8-10 hrs post PCI ] [ Designated as safety issue: No ]CK-MB labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first
Secondary Outcome Measures:
- TIMI flow rates [ Time Frame: During the PCI ] [ Designated as safety issue: No ]
- Incidence of atrial fibrillation, ventricular tachycardia, or ventricular fibrillation in coronary cath lab [ Time Frame: During the PCI ] [ Designated as safety issue: Yes ]
- Incidence of non-sustained ventricular tachycardia or atrial fibrillation post PCI [ Time Frame: Following completion of PCI through hospital discharge ] [ Designated as safety issue: Yes ]
- Left ventricular end diastolic pressure (LVEDP) [ Time Frame: During the PCI ] [ Designated as safety issue: No ]
- Successful PCI, death, myocardial infarction (biomarker greater than 2x normal), CHF, cardiac arrest [ Time Frame: At discharge or within 1 days, whichever comes first ] [ Designated as safety issue: Yes ]
- Death, MI, Revascularization, CHF [ Time Frame: 1-4 weeks post PCI ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | November 2012 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Ranolazine
Oral treatment Intervention: Drug: Ranolazine 1000 mg
|
Drug: Ranolazine
Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI
Other Name: Ranexa
|
|
Placebo Comparator: Placebo
Oral treatment Intervention: Drug: Placebo
|
Drug: Placebo
Drug: Placebo Oral dose twice per day for 3 days leading up to PCI
|
Detailed Description:
Ranolazine has been demonstrated to decrease angina, ischemia on perfusion imaging, improve diastolic function, and cardiac metabolism. Furthermore it has been associated with reduced cardiac arrhythmias, including non-sustained ventricular tachycardia and atrial fibrillation. It has not been studied as an acute cardioprotective agent in percutaneous coronary intervention (PCI).
We hypothesize that upfront administration of Ranolazine could decrease the myocardial injury associated with PCI due to all the factors listed above (i.e. precondition the myocardium). We plan to screen all patients scheduled for an elective coronary angiogram. Those who meet criteria and consent will be randomized to either receive Ranolazine or placebo twice a day for 3 days leading up to the PCI.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 18 or older
- Patients undergoing Coronary Angiography with possible PCI
- Able and willing to give consent
- Able to read and write English
Exclusion Criteria:
- Current EKG or Biomarker of Acute Myocardial Infarction (MI) or Acute Coronary Syndromes (ACS)
- History of Allergy to Ranolazine
- Pregnant or Nursing
- Currently taking Ranolazine
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01767987
Contacts
| Contact: Harvey S Hahn, MD | 937-312-9890 | harvey.hahn@khnetwork.org |
| Contact: Brandi L Palmer, MS | 937-395-8227 | brandi.palmer@khnetwork.org |
Locations
| United States, Ohio | |
| Kettering Medical Center | Recruiting |
| Kettering, Ohio, United States, 45429 | |
| Principal Investigator: Harvey Hahn, MD | |
Sponsors and Collaborators
Harvey Hahn
Gilead Sciences
Investigators
| Principal Investigator: | Harvey S Hahn, MD | Kettering Health Network |
More Information
No publications provided
| Responsible Party: | Harvey Hahn, Director, Cardiovascular Fellowship Training Program and Director, Cardiac Noninvasive Laboratory, Kettering Health Network |
| ClinicalTrials.gov Identifier: | NCT01767987 History of Changes |
| Other Study ID Numbers: | ISR IN-US-259-0139 |
| Study First Received: | November 28, 2012 |
| Last Updated: | May 2, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Kettering Health Network:
|
Acute Coronary Syndrome ACS Percutaneous Coronary Intervention PCI |
Ranolazine Coronary Angiogram Cardioprotectant |
Additional relevant MeSH terms:
|
Acute Coronary Syndrome Myocardial Ischemia Heart Diseases Cardiovascular Diseases Angina Pectoris Vascular Diseases Chest Pain |
Pain Signs and Symptoms Ranolazine Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013