Trial Outcomes & Findings for Ranolazine Cardioprotection in PCI (NCT NCT01767987)

Results Overview

Troponin labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

8-10 hrs post PCI

Results posted on

2017-09-14

Participant Flow

Participant milestones

Participant milestones
Measure	Ranolazine Oral treatment Intervention: Drug: Ranolazine 1000 mg Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI	Placebo Oral treatment Intervention: Drug: Placebo Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI
Overall Study STARTED	4	2
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Ranolazine Oral treatment Intervention: Drug: Ranolazine 1000 mg Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI	Placebo Oral treatment Intervention: Drug: Placebo Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI
Overall Study Physician Decision	4	1

Baseline Characteristics

Ranolazine Cardioprotection in PCI

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ranolazine n=4 Participants Oral treatment Intervention: Drug: Ranolazine 1000 mg Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI	Placebo n=2 Participants Oral treatment Intervention: Drug: Placebo Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI	Total n=6 Participants Total of all reporting groups
Age, Continuous	61.5 years n=5 Participants	67.5 years n=7 Participants	63.5 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 8-10 hrs post PCI

Population: 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.

Troponin labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first

Outcome measures

Outcome measures
Measure	Ranolazine Oral treatment Intervention: Drug: Ranolazine 1000 mg Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI	Placebo n=1 Participants Oral treatment Intervention: Drug: Placebo Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI
Troponin	—	0.023 NG/ML

PRIMARY outcome

Timeframe: 8-10 hrs post PCI

Population: 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.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: TIMI Flow Rate (Grade) is assessed immediately after an interventional reperfusion attempt during a PCI (Percutaneous Coronary Intervention) procedure.

Population: The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom this protocol required data point was collected.

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.

Outcome measures

Outcome measures
Measure	Ranolazine Oral treatment Intervention: Drug: Ranolazine 1000 mg Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI	Placebo n=1 Participants Oral treatment Intervention: Drug: Placebo Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI
TIMI Flow Rate (Grade)	—	3 units on a scale

SECONDARY outcome

Timeframe: During the PCI (Percutaneous Coronary Intervention) procedure - starting at timepoint of guidewire insertion into the access artery until removal of guidewire

Population: The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom these protocol required data points were collected.

Abnormal heart activity

Outcome measures

Outcome measures
Measure	Ranolazine Oral treatment Intervention: Drug: Ranolazine 1000 mg Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI	Placebo n=1 Participants Oral treatment Intervention: Drug: Placebo Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI
Incidence of Atrial Fibrillation, Ventricular Tachycardia, or Ventricular Fibrillation in Coronary Cath Lab	—	0 participants

SECONDARY outcome

Timeframe: Following completion of PCI through hospital discharge

Population: The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom these protocol required data points were collected.

Outcome measures

Outcome measures
Measure	Ranolazine Oral treatment Intervention: Drug: Ranolazine 1000 mg Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI	Placebo n=1 Participants Oral treatment Intervention: Drug: Placebo Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI
Incidence of Non-sustained Ventricular Tachycardia or Atrial Fibrillation Post PCI	—	0 participants

SECONDARY outcome

Timeframe: During the PCI (Percutaneous Coronary Intervention) procedure - starting at timepoint of guidewire insertion into the access artery until removal of guidewire

Population: The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom this protocol required data point was collected.

Outcome measures

Outcome measures
Measure	Ranolazine Oral treatment Intervention: Drug: Ranolazine 1000 mg Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI	Placebo n=1 Participants Oral treatment Intervention: Drug: Placebo Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI
Left Ventricular End Diastolic Pressure (LVEDP)	—	10 mmHG

SECONDARY outcome

Timeframe: At discharge or within 1 days, whichever comes first

Population: The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom these protocol required data points were collected.

Outcome measures

Outcome measures
Measure	Ranolazine Oral treatment Intervention: Drug: Ranolazine 1000 mg Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI	Placebo n=1 Participants Oral treatment Intervention: Drug: Placebo Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI
Death, Myocardial Infarction (Biomarker Greater Than 2x Normal), CHF, Cardiac Arrest	—	0 participants

SECONDARY outcome

Timeframe: 1-4 weeks post PCI

Outcome measures

Outcome measures
Measure	Ranolazine Oral treatment Intervention: Drug: Ranolazine 1000 mg Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI	Placebo n=1 Participants Oral treatment Intervention: Drug: Placebo Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI
Death, MI, Revascularization, CHF	—	0 participants

SECONDARY outcome

Timeframe: At discharge or within 1 days, whichever comes first

Population: The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom these protocol required data points were collected.

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.

Outcome measures

Outcome measures
Measure	Ranolazine Oral treatment Intervention: Drug: Ranolazine 1000 mg Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI	Placebo n=1 Participants Oral treatment Intervention: Drug: Placebo Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI
Successful PCI	—	1 participants

Adverse Events

Ranolazine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Suzanne Coleman, PhD

Kettering Health Network

Phone: 937-395-8390

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place