Acute Coronary SyndromePhase 2NCT01767987

Ranolazine Cardioprotection in PCI

A Phase 2 study testing Ranolazine in people with Acute Coronary Syndrome, run by Harvey Hahn at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The investigators will test if upfront dosing of Ranolazine can reduce myocardial biomarker release (CK-MB, Troponin) post percutaneous coronary intervention (PCI). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Coronary Syndrome
What is being tested?: Ranolazine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 6 participants
Where: 1 siteUnited States
Study dates: Nov 2012to Apr 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 or older
Patients undergoing Coronary Angiography with possible PCI
Able and willing to give consent
Able to read and write English

Who cannot join

Current EKG or Biomarker of Acute Myocardial Infarction (MI) or Acute Coronary Syndromes (ACS)
History of Allergy to Ranolazine
Pregnant or Nursing
Currently taking Ranolazine

Trial locations and contacts

1 site in 1 country.

United States1 site

Kettering Medical Center
Kettering, Ohio, 45429

Other trials in United States

About this study

The investigators will test if upfront dosing of Ranolazine can reduce myocardial biomarker release (CK-MB, Troponin) post percutaneous coronary intervention (PCI).

Read the detailed description

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.

Conditions: Acute Coronary Syndrome
Being tested: Ranolazine, Placebo
Keywords: Acute Coronary Syndrome, ACS, Percutaneous Coronary Intervention, PCI, Ranolazine, Coronary Angiogram, Cardioprotectant
Medical subject headings: Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RanolazineDrug
Also called Ranexa
Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI
PlaceboDrug
Drug: Placebo Oral dose twice per day for 3 days leading up to PCI

Study groups in NCT01767987
Study group	Role	What they receive
Ranolazine	Active comparator	Oral treatment Intervention: Drug: Ranolazine 1000 mg Receives: Drug: Ranolazine
Placebo	Placebo comparator	Oral treatment Intervention: Drug: Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Troponin
Troponin labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first
Measured: 8-10 hrs post PCI
CK-MB
CK-MB labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first
Measured: 8-10 hrs post PCI

Secondary outcomes (7)

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.
Measured: 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
Measured: 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
Measured: Following completion of PCI through hospital discharge
Left Ventricular End Diastolic Pressure (LVEDP)
Measured: 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
Measured: At discharge or within 1 days, whichever comes first
Death, MI, Revascularization, CHF
Measured: 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.
Measured: At discharge or within 1 days, whichever comes first

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2012Apr 2014

First posted15 Jan 2013 (estimated)
Study startNov 2012
Primary completionApr 2014
Study completionApr 2014

Why it stopped: Sponsor terminated study due to lack of enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01767987
Sponsor's protocol ID: ISR IN-US-259-0139
Status last verified: Aug 2017
First submitted: 28 Nov 2012
Last updated: 14 Sep 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
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Comparative Assessment of Inclisiran on Top of Standard of Care Versus Standard of Care Alone for LDL-C Evaluation in Acute Coronary Syndrome Patients in Saudi Arabia
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Optical Coherence Tomography in Acute Vessel Evaluation
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Aspirin for the Prevention of Ischemic Complications in Giant Cell Arteritis
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All Acute Coronary Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ranolazine Cardioprotection in PCI
ClinicalTrials.gov ID: NCT01767987
Acronym / sponsor ID: ISR IN-US-259-0139
Conditions: Acute Coronary Syndrome
Keywords: Acute Coronary Syndrome, ACS, Percutaneous Coronary Intervention, PCI, Ranolazine, Coronary Angiogram, Cardioprotectant
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor terminated study due to lack of enrollment
Enrolment: 6 participants (actual)
Lead sponsor: Harvey HahnUniversity, hospital or other
Collaborators: Gilead Sciences
Study start: Nov 2012
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 15 Jan 2013 (estimated)
Results: Posted 20 Nov 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The investigators will test if upfront dosing of Ranolazine can reduce myocardial biomarker release (CK-MB, Troponin) post percutaneous coronary intervention (PCI).

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Ranolazine	Active comparator	Drug: RanolazineOral treatment Intervention: Drug: Ranolazine 1000 mg
Placebo	Placebo comparator	Drug: PlaceboOral treatment Intervention: Drug: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age 18 or older
Patients undergoing Coronary Angiography with possible PCI
Able and willing to give consent
Able to read and write English

Key exclusion criteria (4 listed)

Current EKG or Biomarker of Acute Myocardial Infarction (MI) or Acute Coronary Syndromes (ACS)
History of Allergy to Ranolazine
Pregnant or Nursing
Currently taking Ranolazine

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RanolazineAlso: RanexaDrug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI	Drug	Ranolazine
PlaceboDrug: Placebo Oral dose twice per day for 3 days leading up to PCI	Drug	Placebo

Primary outcome

Troponin
Time frame: 8-10 hrs post PCI
Troponin labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first
CK-MB
Time frame: 8-10 hrs post PCI
CK-MB labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first

7 secondary outcomes

TIMI Flow Rate (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
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
Time frame: At discharge or within 1 days, whichever comes first

Results and safety

Results posted to the registry on 20 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ranolazine	4	0
Placebo	2	1

Primary outcome: Troponin

Time frame: 8-10 hrs post PCI. Number. Unit: NG/ML

Measure	Ranolazine n = 0	Placebo n = 1
Value	–	0.023

Population analysed: Of the 4 Ranolazine Group subjects, 1 was withdrawn for pre-procedure study drug non-compliance; 3 had no PCI intervention. Of the 2 Placebo Group subject, 1 had no PCI intervention. The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject undergoing this protocol required test.

Primary outcome: CK-MB

Time frame: 8-10 hrs post PCI

Population analysed: For the single subject completing the PCI intervention, CK-MB was not done because the CK level was below the threshold running the CK-MB test.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ranolazine	0 of 4 (0%)	0 of 4 (0%)	Not reported
Placebo	0 of 2 (0%)	0 of 2 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Acute Coronary Syndrome

RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Not yet recruitingPhase 4
Comparative Assessment of Inclisiran on Top of Standard of Care Versus Standard of Care Alone for LDL-C Evaluation in Acute Coronary Syndrome Patients in Saudi Arabia
Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Not yet recruitingPhase 3
Aspirin for the Prevention of Ischemic Complications in Giant Cell Arteritis
Giant Cell Arteritis (GCA), Acute Coronary Syndrome (ACS)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Harvey S Hahn, MD principal investigator

Kettering Health Network

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ranolazine in people with Acute Coronary Syndrome, run by Harvey Hahn at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Troponin (time frame: 8-10 hrs post PCI). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01767987.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2017.