Routinely Deferred Versus Early Intervention in Elderly Patients With Non-ST-elevation Myocardial Infarction (DEAR-OLD)
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|ClinicalTrials.gov Identifier: NCT02900001|
Recruitment Status : Unknown
Verified September 2017 by Yuejin Yang, Chinese Academy of Medical Sciences, Fuwai Hospital.
Recruitment status was: Recruiting
First Posted : September 14, 2016
Last Update Posted : October 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Non-ST Elevation Myocardial Infarction||Procedure: early coronary angiography Procedure: delayed coronary angiography||Not Applicable|
This study aims to enroll 696 elderly patients with non-ST elevation myocardial infarction (NSTEMI) from 20 hospitals throughout mainland China.. Consective patients of 75 years or older with a diagnosis of NSTEMI will be suitable for enrollment. Written informed consent form will be obtained from every patients. Initially stabilized patients with an ischemic episode within 24 hours before admission will be randomized and others will be registered. For randomization, the patients' brief information will be entered in a central randomization system to generate a random number.
According to the random number, each patient will be randomly assigned to early invasive therapy versus routinely deferred invasive strategy. All patients will initiate dual antiplatelet therapy (aspirin+P2Y12 inhibitor) and continued till the end of follow-up at one year. For patients assigned to early invasive group, a loading dose of antiplatelet agent should be given, unless contraindicated. Anticoagulation, anti-ischemic agents, statin and other guideline recommended medicine will be given according to physician in charge according to guideline.
Patients assigned to early invasive strategy will undergo coronary angiography within 24 hours after admission and have percutaneous coronary intervention or coronary artery bypass grafting as soon as possible during the index hospitalization if appropriate. Patients assigned to deferred invasive strategy will undergo coronary angiography and subsequent revascularization after at lest 72 hours after admission and in the index hospitalization. Patients who undergo percutaneous coronary intervention can receive a glycoprotein IIb/IIIa inhibitor if indicated and upfront use of glycoprotein IIb/IIIa inhibitors is discouraged. The choice of intervention or surgery and the choice of complete or staged revascularization will be determined by the operator according to coronary anatomy and consistent with current practice guidelines. Patients assigned to deferred strategy should undergo urgent coronary angiography and revascularization accordingly if indicated during the period of time waiting for catheterization. Such procedure will be adjudicated as an endpoint. Elective percutaneous coronary intervention on non-culprit vessels, in either study arm, can take place sometime after the index procedure with the goal to achieve complete revascularization. Such staged procedures will not be deemed as an adverse event.
Specific data for acquisition:
Research demographics: age, height, weight, body mass index, medications at randomization, pertinent medical/family/social history, i.e., hypertension, hypercholesterolemia, diabetes mellitus, current tobacco use, history of prior myocardial infarction, PCI or CABG. This data will be gathered by research coordinator through interviewing patient and checking patient's medical record.
Procedural: Exact time of onset of ischemic symptoms, of admission, of randomization, and of undertake coronary angiography will be noted by a supplemental chart, along with important information like the evidence of occurrence of an endpoint. Blood concentration of hemoglobin, BNP/NT-proBNP, creatinine, cardiac troponin and C-reaction protein will be tested at admission. First electrocardiography and echocardiography will be recorded. Thrombolysis In Myocardial Infarction flow will be recorded before and after PCI procedure, and the images will be copied to calculate the SYNTAX score afterwards.
After hospital discharge, the research coordinator will contact the patient at specified intervals （30 days after discharge, 180 days and 365 days after randomization） to determine if an endpoint has been met.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||696 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Routinely Deferred Versus Early Invasive Strategy in Chinese Patients of 75 Years or Older With Non-ST-elevation Myocardial Infarction - a Multicenter, Open-label, Randomized Controlled Clinical Trial.|
|Actual Study Start Date :||December 1, 2016|
|Estimated Primary Completion Date :||October 30, 2019|
|Estimated Study Completion Date :||October 30, 2019|
Active Comparator: Early invasive strategy
Patients undergo coronary angiography within 24 hours after admission and have percutaneous coronary intervention or coronary artery bypass grafting as soon as possible during the index hospitalization if appropriate.
Procedure: early coronary angiography
Routine coronary angiography and revascularization if appropriate within 24 hours
Experimental: Deferred invasive strategy
Patients undergo coronary angiography and appropriate revascularization after at lest 72 hours from admission in the index hospitalization.
Procedure: delayed coronary angiography
Routine coronary angiography and revascularization if appropriate after 72 hours
- Composite endpoint of all-cause mortality, non-lethal myocardial infarction, stroke and urgent revascularization [ Time Frame: 1 year ]
- No reflow [ Time Frame: during PCI ]composite and Individual component
- All-cause mortality [ Time Frame: 30 days after discharge, 6 months and 1 year after randomization ]composite and Individual component
- Non-lethal myocardial infarction [ Time Frame: 30 days after discharge, 6 months and 1 year after randomization ]composite and Individual component
- Severe recurrent ischemia [ Time Frame: 30 days after discharge, 6 months and 1 year after randomization ]composite and Individual component
- Stroke [ Time Frame: 30 days after discharge, 6 months and 1 year after randomization ]composite and Individual component
- Major bleeding [ Time Frame: 30 days after discharge, 6 months and 1 year after randomization ]composite and Individual component
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): NCT02900001
|Contact: Jingang Yang, M.D.||+firstname.lastname@example.org|
|Contact: Wen-Xiu Leng, M.D.||+email@example.com|
|Beijing, Beijing, China, 100037|
|Contact: Yue-Jin Yang, MD|
|Principal Investigator:||Yuejin Yang, M.D., PhD.||National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Fuwai Hospital|