Ranolazine Loading to Prevent PCI-induced Myocardial Injury
TWILIGHT
TWice overnIght High-dose ranoLazIne Pretreatment for preventinG Myocardial iscHemic Damage in Patients With Stable Angina Undergoing percuTaneous Coronary Intervention
1 other identifier
interventional
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 coronary-artery-disease
Started Jan 2014
Typical duration for phase_4 coronary-artery-disease
1 active site
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
First Submitted
Initial submission to the registry
December 8, 2011
CompletedFirst Posted
Study publicly available on registry
December 13, 2011
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMarch 7, 2013
March 1, 2013
1.9 years
December 8, 2011
March 6, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Assessment of post-PCI peak values of markers of myocardial damage
Baseline and 48 hours after PCI
Rate of 30-day MACE
Up to 30 days after PCI
Study Arms (2)
Ranolazine
ACTIVE COMPARATORAdministration of two preprocedural doses of Ranolazine 12 hours apart (1,000 mg the night before PCI and 1,000 mg prior to PCI)
Placebo
PLACEBO COMPARATORPlacebo
Interventions
os, 1,000 mg twice 12 hours apart prior to PCI
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Raffaele Pisana
Rome, 00100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 8, 2011
First Posted
December 13, 2011
Study Start
January 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2017
Last Updated
March 7, 2013
Record last verified: 2013-03