Clinical Trial Results:
Reduction of Ischemic Myocardium with Ranolazine-Treatment in patients with acute myocardial Ischemia – RIMINI-Pilot-Trial
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Summary
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EudraCT number |
2013-000030-35 |
Trial protocol |
DE |
Global end of trial date |
05 Jun 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
10 Sep 2022
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First version publication date |
10 Sep 2022
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Other versions |
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Summary report(s) |
RIMINI_Synopsis Final Report |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
RIMINI-Pilot
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01797484 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
University Medical Center Hamburg-Eppendorf
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Sponsor organisation address |
Martinistr. 52, Hamburg, Germany, 20246
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Public contact |
Dr. Peter Clemmensen, University Medical Center Hamburg-Eppendorf, +49 40741053979, p.clemmensen@uke.de
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Scientific contact |
Dr. Peter Clemmensen, University Medical Center Hamburg-Eppendorf, +49 40741053979, p.clemmensen@uke.de
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
15 Dec 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
05 Jun 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
05 Jun 2015
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Area of ischemic myocardium/cm² (longitudinal strain, radial/circumferential strain) after 42 days treatment with Ranolazine
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Protection of trial subjects |
Concerning risk/benefit consideration it is important to state that in the present trial the IMP was used within its approval according to the SmPC. Therefore an excessive risk for participating patients was not expected.
Each participant was involved in the study for a maximum of 42 days. Patients needed to attend on 3 occasions. There was the possibility of additional visits at the request of the subject or if this was considered clinically necessary.
Specific inclusion and exclusion criteria and a defined visit plan for monitoring the patients were included in the protocol.
Screening/Enrolment/Day 0 Written informed consent, blood sampling, echocardiography, medical history
Visit 1 (week 1) assessment, dosage increase
Visit 2 (week 2) assessment, blood sampling
Visit 3 (week 6) assessment, echocardiography, ECG
Criteria for Discontinuation Study Treatment for all patients
Discontinue study medication in the following instances:
• Discontinuation of study at the request of sponsor, Regulatory Agency or an EC
• Termination of study by Sponsor
• Medication-related toxicity > Grade 4 in more than 10 % of study population
• More than 2 Serious Adverse Events or SUSARs, which were judged as related to the study medication
• Indication that either of the study arms is associated with an accelerated clinical progression (stopp of study at the decision of Investigator after discussion with Sponsor)
Criteria for Discontinuation of Study Treatment for the Single Patient
• Any clinical AE, laboratory abnormality or intercurrent illness, which in opinion of the Investigator, indicates that continued treatment with study therapy is not in the best interest of the subject
• Subject withdraws consent
• Pregnancy or breast-feeding during study
• Imprisonment or the compulsory detention for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
• Discontinuations mandated by protocol defined safety parameters
• Requireme
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Apr 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Germany: 20
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Worldwide total number of subjects |
20
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EEA total number of subjects |
20
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
10
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From 65 to 84 years |
9
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85 years and over |
1
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Recruitment
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Recruitment details |
First patient enrolled: 05-Aug-2013 Last patient finished: 05-Jun-2015 All patients were enrolled at the University Heart Centre Hamburg Eppendorf. A total of 20 patients with acute coronary syndrome and proof of myocardial dyskinesia were enrolled. | |||||||||
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Pre-assignment
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Screening details |
Proof of acute cardiac ischemia (elevated serum Troponine) Proof of myocardial dyskinesia with functional ECG (“speckle tracking”) Stable angina pectoris >/= CCS II in patient history Stabilized patients after coronary angioplasty or angiography coronary angioplasty or angiography not older than 48h Established standard therapy for CAD | |||||||||
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Period 1
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Blinding implementation details |
Only the cardiology specialist performing speckle-tracking ECG was blinded to the treatment regime of the patient undergoing examination.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Ranolazine | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Ranolazine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Ranolazine was administered as one tablet orally twice a day. Dosage started with 500mg bid and was increased to 750mg bid after seven days of treatment as described in the Summary of Product Characteristics. Duration of treatment was 42 days.
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Arm title
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no additional medication | |||||||||
Arm description |
- | |||||||||
Arm type |
no additional medication | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
Ranolazine
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
no additional medication
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Ranolazine
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Reporting group description |
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Reporting group title |
no additional medication
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Reporting group description |
- | ||
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End point title |
Area of ischemic Myocardium/cm² (longitudinal strain, radial/circumferential strain) after 42 days treatment with Ranolazine | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
42 days after first dose of Ranolazine
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Statistical analysis title |
Baseline Adjusted Analysis | ||||||||||||
Statistical analysis description |
Analysis between Ranolazine treatment and no additional treatment were carried out using paired t-test. Non-parametric Mann-Whitney test were used for data that are not normally distributed. Categorical parameters were analyzed using χ2 and exact Fisher’s test.
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Comparison groups |
Ranolazine v no additional medication
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Number of subjects included in analysis |
20
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Analysis specification |
Pre-specified
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Analysis type |
other [1] | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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| Notes [1] - proof of concept |
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Adverse events information [1]
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Timeframe for reporting adverse events |
AEs were collected for all patients from first dose of protocol treatment until 30 days after the last dose of treatment with a protocol IMP.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
na
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Reporting groups
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Reporting group title |
Ranolazine
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
no additional medication
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: AEs were collected for all patients from first dose of protocol treatment until 30 days after the last dose of treatment with a protocol IMP. Information about AEs, whether volunteered by the patient, discovered by the investigator questioning or detected through physical examination, laboratory test or other investigation were collected and recorded in the study files. No reporting of AEs. |
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| Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/29938533 |
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