Ticagrelor Versus Clopidogrel in Left Ventricular Remodeling After ST-segment Elevation Myocardial Infarction (HEALING-AMI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02224534|
Recruitment Status : Unknown
Verified November 2016 by Yongwhi Park, Gyeongsang National University Hospital.
Recruitment status was: Recruiting
First Posted : August 25, 2014
Last Update Posted : November 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|ST Elevation Myocardial Infarction||Drug: Ticagrelor Drug: Clopidogrel||Phase 4|
The investigators designed the HEALING-AMI study to compare the influence of ticagrelor (180 mg loading and 90 mg twice daily maintenance) vs. clopidogrel (600 mg loading and 75 mg daily maintenance) on long-term left ventricular (LV) remodeling measured by 3D echocardiography in STEMI patients undergoing primary PCI.
The primary objective of the HEALING-AMI study is to demonstrate the novel role of long-term ticagrelor therapy in reducing the risk of LV remodeling,. The secondary objectives are to reveal the cross-talk between platelet and inflammatory process in ST-segment elevation myocardial infarction (STEMI) patients. Moreover, this study will determine whether the high platelet inhibition by ticagrelor culminate the protection of infarcted myocardium.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||326 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||High PlatElet Inhibition With TicAgrelor to Improve Left Ventricular RemodeLING in Patients With ST-segment ElevAtion Myocardial Infarction: the HEALING-AMI Trial.|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: Ticagrelor and Clopidogrel.
The patients assigned to the TICA group have loading dose of ticagrelor 180 mg just after the randomization, and then ticagrelor 90 mg twice daily during the study period. All patients also have aspirin 300 mg as a loading dose and 100 mg once daily as a maintenance dose.
Ticagrelor 180 mg as a loading dose and 90 mg twice daily as a maintenance dose
Other Name: Brillinta
Active Comparator: Clopidogrel
The patients assigned to the CLPD group have loading dose of clopidogrel 600 mg just after the randomization, and then clopidogrel 75 mg daily should be maintained during the study period. All patients also have aspirin 300 mg as a loading dose and 100 mg once daily as a maintenance dose.
Clopidogrel 600 mg as a loading dose and 75 mg once daily as a maintenance dose.
Other Name: Plavix
- LV remodeling index (%) [ Time Frame: Interval change between baseline and 6 months after the index events ]
Real time 3D-echocardiography data sets will be analyzed with available 4D-LV Analysis software (e.g. TomTec Imaging Systems, Unterschleisheim, Germany) in the core lab.
Left ventricular (LV) remodeling index: a relative change in LV end-diastolic volume (LVEDV) seen at 6-month follow-up compared with the baseline during admission.
- NT-proBNP level at 6 months [ Time Frame: 6 months after the index events ]
- Absolute change of LVESVI, LVEDVI and LVEF [ Time Frame: Interval change between baseline and 6 months after the index events ]
- Prevalence of adverse LV remodeling [ Time Frame: Interval change between baseline and 6 months after the index events ]Adverse LV remodeling: a relative > 20% increase in LVEDV seen at 6-month follow-up compared with the baseline during admission.
- Level of platelet reactivity [ Time Frame: At the time of PCI, 3 days and 1 month after the events ]Measured by VerifyNow P2Y12 assay
- Post-PCI angiographic perfusion indicators: TIMI flow grade, myocardial blush grade, corrected TIMI frame count [ Time Frame: Just after primary PCI ]
- EKG change: ST-segment elevation resolution (%), complete ST-segment resolution [ Time Frame: Baseline, 60 minutes after the PCI. ]complete ST-segment resolution: ST-segment resolution ≥70%
- Level of hs-CRP [ Time Frame: At the time of PCI, 1 month and 6 months after the events ]
- Bleeding events based on BARC or PLATO definition [ Time Frame: 6 months after the events ]
BARC definition for bleeding is defined as type 1, 2, 3 (3a, 3b and 3c), 4, and 5 (5a and 5b), according to the Bleeding Academic Research Consortium classification.
- Type 1 (nuisance or superficial bleeding).
- Type 2 (internal bleeding).
- Type 3a (TIMI minor bleeding).
- Type 3b (TIMI major bleeding).
- Type 3c (life threatening bleeding).
- Type 4 (CABG-related bleeding).
- Type 5a (probable fatal bleeding).
- Type 5b (definite fatal bleeding). Bleeding events pertaining to type 1 to 3a are considered as minor bleeding and those pertaining to type 3b to 5b as major bleeding.
PLATO definition for bleeding
- Major life-threatening bleeding.
- Other major bleeding.
- Minor bleeding.
The case report form (CRF) collects the event history of bleeding during admission and at 1 month and 6 months. Occurrences of major, minor, and combined major and minor bleeding events will be compared between groups.
- Cardiac MRI (Substudy): LV remodeling index [ Time Frame: Three days and 6 months after the events ]Measured at A*STAR-NUS Clinical Imaging Research Centre, Singapore
- Level of inflammatory markers (Substudy) [ Time Frame: During hospitalization and at 1 month after the events ]
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): NCT02224534
|Contact: Yongwhi Park, MD.,PhD.||+firstname.lastname@example.org|
|Contact: Young-Hoon Jeong, MD.,PhD.||+email@example.com|
|Chinese PLA General Hospital||Not yet recruiting|
|Principal Investigator: Yundai Chen, MD.|
|Korea, Republic of|
|Chonnam National University Hospital||Recruiting|
|Gwangju, CHONRANAM-Do, Korea, Republic of|
|Contact: Young-Joon Hong, MD, PhD|
|Seoul National University Bundang Hospital||Recruiting|
|Bundang, Gyeongki-do, Korea, Republic of|
|Contact: Jeong-Won Suh, MD, PhD|
|Changwon Samsung Medical Center||Recruiting|
|Changwon, Korea, Republic of|
|Principal Investigator: Ju Hyeon Oh, MD|
|Chungbuk National University Hospital||Recruiting|
|Chungju, Korea, Republic of|
|Principal Investigator: Sang Yeub Lee, MD.|
|Kyungpook National University Hospital||Recruiting|
|Daegu, Korea, Republic of|
|Principal Investigator: Jang Hoon Lee, MD|
|Chungnam National University Hospital||Recruiting|
|Daejeon, Korea, Republic of|
|Principal Investigator: Jae-Hyeong Park, MD.|
|Gyeongsang National University Hospital||Recruiting|
|Korea, Korea, Republic of, 660-702|
|Principal Investigator: Yongwhi Park, MD.,PhD.|
|Principal Investigator: Young-Hoon Jeong, MD.,PhD.|
|Kyung Hee University Hospital||Recruiting|
|Seoul, Korea, Republic of|
|Principal Investigator: Won Kim, MD.|
|Ulsan University Hospital||Recruiting|
|Ulsan, Korea, Republic of|
|Principal Investigator: Eun-Seok Shin, MD.|
|Pusan National University Yangsan Hospital||Recruiting|
|Yangsan, Korea, Republic of|
|Principal Investigator: Jeong Su Kim, MD.|
|National University Heart Centre||Active, not recruiting|
|Principal Investigator:||Yongwhi Park, MD., PhD.||Gyeongsang National University Hospital|
|Principal Investigator:||Young-Hoon Jeong, MD.,PhD.||Gyeongsan National University Hospital|