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Ranolazine Loading to Prevent PCI-induced Myocardial Injury (TWILIGHT)

This study is not yet open for participant recruitment.
Verified March 2013 by University of Roma La Sapienza
Sponsor:
Information provided by (Responsible Party):
Francesco Pelliccia, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01491061
First received: December 8, 2011
Last updated: March 6, 2013
Last verified: March 2013
History of Changes
  Purpose

It has previously been shown that pretreatment with ranolazine 1,000 mg twice daily for 7 days can significantly reduce procedural myocardial injury in elective percutaneous coronary intervention (PCI). The investigators tested the hypothesis that twice overnight high-dose ranolazine loading before PCI can reduce the peri-procedural myocardial ischemic damage similarly to long-term pre-treatment with standard doses.


Condition Intervention Phase
Coronary Artery Disease
 Drug: Ranolazine
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: TWice overnIght High-dose ranoLazIne Pretreatment for preventinG Myocardial iscHemic Damage in Patients With Stable Angina Undergoing percuTaneous Coronary Intervention

Resource links provided by NLM:

Drug Information available for: Ranolazine
U.S. FDA Resources

Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • Frequency of PCI-induced myocardial infarction [ Time Frame: Up to 48 hours after PCI ] [ Designated as safety issue: No ]
    Occurrence of peri-procedural myocardial infarction (i.e. creatine kinase-MB>3 times the upper reference limit)


Secondary Outcome Measures:
  • Assessment of post-PCI peak values of markers of myocardial damage [ Time Frame: Baseline and 48 hours after PCI ] [ Designated as safety issue: No ]
    Changes after percutaneous coronary intervention in absolute values of creatine kinase, creatine kinase-MB, myoglobin, and troponin I

  • Rate of 30-day MACE [ Time Frame: Up to 30 days after PCI ] [ Designated as safety issue: No ]
    30-day incidence of major adverse cardiac events (MACE—death, myocardial infarction, target vessel revascularization)


Estimated Enrollment: 100
Study Start Date: January 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ranolazine
Administration of two preprocedural doses of Ranolazine 12 hours apart (1,000 mg the night before PCI and 1,000 mg prior to PCI)
 Drug: Ranolazine
os, 1,000 mg twice 12 hours apart prior to PCI
Other Name: Ranexa TM, Gilead, USA
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
os, two doses 12 hours apart prior to PCI
Other Name: Placebo

Detailed Description:

Background

Ranolazine is a novel antianginal drug that reduces intracellular sodium and calcium accumulation during ischemia thus limiting ischemic injury.

It has previously been shown that pretreatment with ranolazine 1,000 mg twice daily for 7 days can significantly reduce procedural myocardial injury in elective percutaneous coronary intervention.

It remains unknown, however, which of these two therapeutic approaches is more effective after PCI.

Purpose

The primary objective of this study is to test the hypothesis that twice overnight high-dose ranolazine loading before PCI can reduce the peri-procedural myocardial ischemic damage similarly to long-term pre-treatment with standard doses.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Angiographically-proven coronary artery disease
  • Class I indication to elective percutaneous coronary intervention
  • Stable conditions
  • No recent acute coronary syndromes
  • Normal baseline values of markers of myocardial damage (creatine kinase, creatine kinase-MB, myoglobin, and troponin I)
  • Able to understand and willing to sign the informed consent form

Exclusion Criteria:

• Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01491061

Contacts
Contact: Francesco Pelliccia, MD +393483392006 f.pelliccia@mclink.it

Locations
Italy
San Raffaele Pisana Not yet recruiting
Rome, Italy, 00100
Contact: Giuseppe Marazzi, MD     +39 335 8381320     giuseppe.marazzi@yahoo.com    
Sponsors and Collaborators
University of Roma La Sapienza
  More Information

No publications provided

Responsible Party: Francesco Pelliccia, Assistant Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01491061     History of Changes
Other Study ID Numbers: 653/2011/D
Study First Received: December 8, 2011
Last Updated: March 6, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by University of Roma La Sapienza:
periprocedural myocardial infarction
ranolazine

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Ranolazine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013