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Effect of Trimetazidine During the Primary PCI on Cardiac Function in Patients With ST-elevation Myocardial Infarction

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ClinicalTrials.gov Identifier: NCT02826616
Recruitment Status : Enrolling by invitation
First Posted : July 11, 2016
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
Qian geng, Chinese PLA General Hospital

Brief Summary:
Giving preoperative loading dose of 60mg of trimetazidine can safely and effectively reduce the PCI-related myocardial damage for the patients undergoing selective PCI. but the effect of Trimetazidine during the primary PCI on cardiac function in patients with ST-elevation myocardial infarction is not sure. this study aim to study the effect of Trimetazidine during the primary PCI on cardiac function in patients with ST-elevation myocardial infarction.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Drug: Trimetazidine Not Applicable

Detailed Description:

Investigators will enroll 240 patients with STEMI who were admitted to the Chinese PLA General Hospital between Januay 2017 and August 2017. STEMI was defined as typical chest pain lasting 30 min within the previous 12 h, a clear ST-segment elevation of N0.1 mV in ≥2 contiguous electrocardiographic leads, and elevated blood levels of troponin T. We randomly assign eligible patients in a 1:1 ratio to either 60mg of trimetazidine or oral placebo befor PCI. Trimetazidine group will accept 20mg of trimetazidine for 12 months after PCI and active Comparator will be given placebo for 12 months after PCI.

Primary end point of the study was the area of viable myocardium coming from MR delayed enhancement scan and main cardiovascular events concluding recurrent myocardial infarction, cardiac death, recurrent angina, acute heart failure. Secondary end point of the study was the change of LVEF. All adverse clinical events as well as study end points were monitored and adjudicated by the independent event committee. Each patient was contacted in every week after administration of the contrast, investigated main cardiovascular events (myocardial infarction,acute heart failure and death), and record any adverse events.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chinese People's Liberation Army General Hospital
Study Start Date : July 2016
Estimated Primary Completion Date : August 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Trimetazidine group
Trimetazidine 60 mg 30 min before PCI and 20 mg for 12 months after surgery
Drug: Trimetazidine
Trimetazidine 60 mg 30min before PCI and 20 mg for 12 months after surgery
No Intervention: The control group
placebo 60 mg 30 min before PCI and 20 mg for 12 months after surgery



Primary Outcome Measures :
  1. TIMI flow grade [ Time Frame: immediately post procedure ]
  2. Myocardial infarct size according to MR delayed enhancement scan [ Time Frame: 3 to 5 days after PCI ]
  3. main cardiovascular events [ Time Frame: follow up in one year ]

Secondary Outcome Measures :
  1. change of the LVEF [ Time Frame: follow up in one year ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • STEMI patients: typical chest pain lasting 30 min within the previous 12 h, a clear ST-segment elevation of N0.1 mV in ≥2 contiguous electrocardiographic leads, and elevated blood levels of troponin T
  • patients were scheduled to undergo diagnostic cardiac angiography or percutaneous coronary interventions

Exclusion Criteria:

  • The combined use of trimetazidine contraindications;
  • had cardiogenic shock,
  • had a history of myocardial infarction, stent thrombosis, or renal insufficiency;
  • had previously undergone coronary artery bypass surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02826616


Locations
China, Beijing
Chinese People's Liberation Army General Hospital
Peking, Beijing, China, 100853
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
Study Chair: Dai Yun Chen, MD Chinese PLA General Hospital

Publications:

Responsible Party: Qian geng, Chinese People's Liberation Army General Hospital, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02826616     History of Changes
Other Study ID Numbers: 1672sdd
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016

Keywords provided by Qian geng, Chinese PLA General Hospital:
Trimetazidine
ST-segment elevation myocardial
Reperfusion injury
Percutaneous coronary intervention

Additional relevant MeSH terms:
Cardiovascular Diseases
ST Elevation Myocardial Infarction
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Vascular Diseases
Trimetazidine
Vasodilator Agents