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Reduction of Ischemic Myocardium With Ranolazine-Treatment in Patients With Acute Myocardial Ischemia (RIMINI-Pilot)

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ClinicalTrials.gov Identifier: NCT01797484
Recruitment Status : Completed
First Posted : February 22, 2013
Results First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Tjark Frederik Schwemer, Universitätsklinikum Hamburg-Eppendorf

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Coronary Artery Disease
Acute Myocardial Ischemia
Intervention: Drug: Ranolazine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

first patient enrolled: 05-Aug-2013 last patient finished: 05-Jun-2015

All patients were enrolled at University Heart Centre Hamburg Eppendorf


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
n.a.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Ranolazine   No Additional Medication
STARTED   10   10 
COMPLETED   10   10 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
   Ranolazine   No Additional Medication   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   20 
Age 
[Units: Years]
Mean (Standard Deviation)
 68  (9)   72  (7)   70  (8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  40.0%      5  50.0%      9  45.0% 
Male      6  60.0%      5  50.0%      11  55.0% 


  Outcome Measures

1.  Primary:   Left Ventricular Global Strain Rate   [ Time Frame: 42 days after first dose of Ranolazine ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Tjark F. Schwemer
Organization: University Heart Centre Hamburg Eppendorf
phone: +49 40 7410 ext 56800
e-mail: t.schwemer@uke.de


Publications:


Responsible Party: Tjark Frederik Schwemer, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01797484     History of Changes
Other Study ID Numbers: UHZ-KARD-01-2013
First Submitted: February 20, 2013
First Posted: February 22, 2013
Results First Submitted: April 25, 2016
Results First Posted: January 12, 2018
Last Update Posted: January 12, 2018