Ranolazine Loading to Prevent PCI-induced Myocardial Injury

Coronary Artery Disease Clinical Trial

— TWILIGHT  

Official title:

TWice overnIght High-dose ranoLazIne Pretreatment for preventinG Myocardial iscHemic Damage in Patients With Stable Angina Undergoing percuTaneous Coronary Intervention

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01491061
• Other study ID #: 653/2011/D
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 8, 2011
• Last updated: March 6, 2013
• Start date: January 2014
• Est. completion date: December 2017

Study information

• Verified date: March 2013
• Source: University of Roma La Sapienza
• Contact: Francesco Pelliccia, MD
• Phone: +393483392006
• Email: f.pelliccia[@]mclink.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Ranolazine
os, 1,000 mg twice 12 hours apart prior to PCI
• Placebo
os, two doses 12 hours apart prior to PCI

Locations

Country	Name	City	State
Italy	San Raffaele Pisana	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of PCI-induced myocardial infarction	Occurrence of peri-procedural myocardial infarction (i.e. creatine kinase-MB>3 times the upper reference limit)	Up to 48 hours after PCI	No
Secondary	Assessment of post-PCI peak values of markers of myocardial damage	Changes after percutaneous coronary intervention in absolute values of creatine kinase, creatine kinase-MB, myoglobin, and troponin I	Baseline and 48 hours after PCI	No
Secondary	Rate of 30-day MACE	30-day incidence of major adverse cardiac events (MACE—death, myocardial infarction, target vessel revascularization)	Up to 30 days after PCI	No