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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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

December 8, 2011
March 6, 2013
January 2014
December 2015   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01491061 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Ranolazine Loading to Prevent PCI-induced Myocardial Injury
TWice overnIght High-dose ranoLazIne Pretreatment for preventinG Myocardial iscHemic Damage in Patients With Stable Angina Undergoing percuTaneous Coronary Intervention

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Coronary Artery Disease
  • Drug: Ranolazine
    os, 1,000 mg twice 12 hours apart prior to PCI
    Other Name: Ranexa TM, Gilead, USA
  • Drug: Placebo
    os, two doses 12 hours apart prior to PCI
    Other Name: Placebo
  • 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)
    Intervention: Drug: Ranolazine
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
December 2017
December 2015   (final data collection date for primary outcome measure)

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

Both
Not Provided
No
Contact: Francesco Pelliccia, MD +393483392006 f.pelliccia@mclink.it
Italy
 
NCT01491061
653/2011/D
No
Francesco Pelliccia, University of Roma La Sapienza
University of Roma La Sapienza
Not Provided
Not Provided
University of Roma La Sapienza
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP