Trial Outcomes & Findings for Reduction of Ischemic Myocardium With Ranolazine-Treatment in Patients With Acute Myocardial Ischemia (NCT NCT01797484)

Results Overview

Relativ acceleration or deceleration (1/s) of left ventricular myocardial sections compared to direct opposite section. The more positive the value, the more simultaneously the movements, the more hemodynamically better.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

20 participants

Primary outcome timeframe

42 days after first dose of Ranolazine

Results posted on

2018-01-12

Participant Flow

first patient enrolled: 05-Aug-2013 last patient finished: 05-Jun-2015 All patients were enrolled at University Heart Centre Hamburg Eppendorf

Participant milestones

Participant milestones
Measure	Ranolazine Ranolazine 500mg bid orally 7 days Ranolazine 750mg bid orally 35 days Ranolazine: Improvement of myocardial microcirculation	No Additional Medication No additional medication - control group
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reduction of Ischemic Myocardium With Ranolazine-Treatment in Patients With Acute Myocardial Ischemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ranolazine n=10 Participants Ranolazine 500mg bid orally 7 days Ranolazine 750mg bid orally 35 days Ranolazine: Improvement of myocardial microcirculation	No Additional Medication n=10 Participants No additional medication - control group	Total n=20 Participants Total of all reporting groups
Age, Continuous	68 years STANDARD_DEVIATION 9 • n=5 Participants	72 years STANDARD_DEVIATION 7 • n=7 Participants	70 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: 42 days after first dose of Ranolazine

Population: Secondary Outcome Measure data was not collected. Initially planned secondary outcome (e.g. cardiac events) was found to interfere with monitoring drug safety

Relativ acceleration or deceleration (1/s) of left ventricular myocardial sections compared to direct opposite section. The more positive the value, the more simultaneously the movements, the more hemodynamically better.

Outcome measures

Outcome measures
Measure	Ranolazine n=10 Participants Ranolazine 500mg bid orally 7 days Ranolazine 750mg bid orally 35 days Ranolazine: Improvement of myocardial microcirculation	No Additional Medication n=10 Participants No additional medication - control group
Left Ventricular Global Strain Rate	18 percentage of change Standard Deviation 2	23 percentage of change Standard Deviation 3

Adverse Events

Ranolazine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Additional Medication

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

Dr. Tjark F. Schwemer

University Heart Centre Hamburg Eppendorf

Phone: +49 40 7410

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place