A Phase 2 interventional study of Ranolazine and Placebo in Acute Coronary Syndrome, sponsored by Harvey Hahn. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-14.
Sponsored by Harvey Hahn · Phase 2, Interventional, and Prevention
The investigators will test if upfront dosing of Ranolazine can reduce myocardial biomarker release (CK-MB, Troponin) post percutaneous coronary intervention (PCI).
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.
1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.
This study's enrollment of 6 is below the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →This is the only study on the registry with Harvey Hahn as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Oral treatment Intervention: Drug: Ranolazine 1000 mg
Drug: Ranolazine
Oral treatment Intervention: Drug: Placebo
Drug: Placebo
Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI
Also known as: Ranexa
Drug: Placebo Oral dose twice per day for 3 days leading up to PCI
Troponin
Troponin labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first
Time frame: 8-10 hrs post PCI
CK-MB
CK-MB labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first
Time frame: 8-10 hrs post PCI
TIMI Flow Rate (Grade)
This TIMI classification was developed by the TIMI (Thrombolysis In Myocardial Infarction) study group to semiquantitatively assess coronary artery perfusion beyond point of occlusion on coronary angiography.\* TIMI Grade \[Description\] TIMI 0 - no perfusion \[no antegrade flow beyond the point of occlusion\] TIMI 1 - penetration without perfusion \[faint antegrade coronary flow beyond the occlusion with incomplete filling of the distal coronary bed\] TIMI 2 - partial perfusion \[delayed or sluggish antegrade flow with complete filling of the distal territory\] TIMI 3 - complete perfusion \[normal flow with complete filling of the distal territory\] \*(see http://radclass.mudr.org/content/timi-grade-flow-grading-coronary-blood-flow-during-coronary-angiography) TIMI 0 is the least favorable grade. TIMI 3 is the most favorable grade.
Time frame: TIMI Flow Rate (Grade) is assessed immediately after an interventional reperfusion attempt during a PCI (Percutaneous Coronary Intervention) procedure.
Incidence of Atrial Fibrillation, Ventricular Tachycardia, or Ventricular Fibrillation in Coronary Cath Lab
Abnormal heart activity
Time frame: During the PCI (Percutaneous Coronary Intervention) procedure - starting at timepoint of guidewire insertion into the access artery until removal of guidewire
Incidence of Non-sustained Ventricular Tachycardia or Atrial Fibrillation Post PCI
Time frame: Following completion of PCI through hospital discharge
Left Ventricular End Diastolic Pressure (LVEDP)
Time frame: During the PCI (Percutaneous Coronary Intervention) procedure - starting at timepoint of guidewire insertion into the access artery until removal of guidewire
Death, Myocardial Infarction (Biomarker Greater Than 2x Normal), CHF, Cardiac Arrest
Time frame: At discharge or within 1 days, whichever comes first
Death, MI, Revascularization, CHF
Time frame: 1-4 weeks post PCI
Successful PCI
For the purposes of this study, a successful PCI is considered one where no additional coronary interventions were required within 24 hours after the initial PCI.
Time frame: At discharge or within 1 days, whichever comes first
| Milestone | Ranolazine | Placebo |
|---|---|---|
| Started | 4 | 2 |
| Completed | 0 | 1 |
| Not completed | 4 | 1 |
| Withdrew: Physician decision | 4 | 1 |
Troponin labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first
| NG/ML | Ranolazine | Placebo |
|---|---|---|
| Troponin | — | 0.023 |
CK-MB labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first
No measurements were reported for this outcome.
This TIMI classification was developed by the TIMI (Thrombolysis In Myocardial Infarction) study group to semiquantitatively assess coronary artery perfusion beyond point of occlusion on coronary angiography.\* TIMI Grade \[Description\] TIMI 0 - no perfusion \[no antegrade flow beyond the point of occlusion\] TIMI 1 - penetration without perfusion \[faint antegrade coronary flow beyond the occlusion with incomplete filling of the distal coronary bed\] TIMI 2 - partial perfusion \[delayed or sluggish antegrade flow with complete filling of the distal territory\] TIMI 3 - complete perfusion \[normal flow with complete filling of the distal territory\] \*(see http://radclass.mudr.org/content/timi-grade-flow-grading-coronary-blood-flow-during-coronary-angiography) TIMI 0 is the least favorable grade. TIMI 3 is the most favorable grade.
| units on a scale | Ranolazine | Placebo |
|---|---|---|
| TIMI Flow Rate (Grade) | — | 3 |
Abnormal heart activity
| participants | Ranolazine | Placebo |
|---|---|---|
| Incidence of Atrial Fibrillation, Ventricular Tachycardia, or Ventricular Fibrillation in Coronary Cath Lab | — | 0 |
| participants | Ranolazine | Placebo |
|---|---|---|
| Incidence of Non-sustained Ventricular Tachycardia or Atrial Fibrillation Post PCI | — | 0 |
| mmHG | Ranolazine | Placebo |
|---|---|---|
| Left Ventricular End Diastolic Pressure (LVEDP) | — | 10 |
| participants | Ranolazine | Placebo |
|---|---|---|
| Death, Myocardial Infarction (Biomarker Greater Than 2x Normal), CHF, Cardiac Arrest | — | 0 |
| participants | Ranolazine | Placebo |
|---|---|---|
| Death, MI, Revascularization, CHF | — | 0 |
For the purposes of this study, a successful PCI is considered one where no additional coronary interventions were required within 24 hours after the initial PCI.
| participants | Ranolazine | Placebo |
|---|---|---|
| Successful PCI | — | 1 |
Collected over Adverse event data was collected from time of consent through end of study discharge from hospital. Adverse events unresolved at discharge were to be followed to resolution. No events occuring after discharge were to be recorded as adverse events.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ranolazine | — | 0/4 (0%) | 0/4 (0%) |
| Placebo | — | 0/2 (0%) | 0/2 (0%) |
| Age, Continuous(years) | Ranolazine | Placebo | Total |
|---|---|---|---|
| Mean | 61.5 (51 to 66) | 67.5 (65 to 70) | 63.5 (51 to 70) |
| Age, Categorical(Participants) | Ranolazine | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 0 | 2 |
| >=65 years | 2 | 2 | 4 |
| Sex: Female, Male(Participants) | Ranolazine | Placebo | Total |
|---|---|---|---|
| Female | 3 | 1 | 4 |
| Male | 1 | 1 | 2 |
| Region of Enrollment(participants) | Ranolazine | Placebo | Total |
|---|---|---|---|
| United States | 4 | 2 | 6 |
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.