Routinely Deferred Versus Early Intervention in Elderly Patients With Non-ST-elevation Myocardial Infarction
DEAR-OLD
1 other identifier
interventional
696
1 country
1
Brief Summary
This study is to evaluate the efficacy and safety of a routinely deferred invasive strategy in comparison with an early invasive strategy in Chinese elderly patients of 75 years or older with non-ST elevation myocardial infarction, aiming to test the hypothesis that routinely deferred invasive strategy is not inferior to early invasive strategy in such an elderly group of patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2016
CompletedFirst Posted
Study publicly available on registry
September 14, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2019
CompletedOctober 3, 2017
September 1, 2017
2.9 years
August 24, 2016
September 29, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite endpoint of all-cause mortality, non-lethal myocardial infarction, stroke and urgent revascularization
1 year
Secondary Outcomes (6)
No reflow
during PCI
All-cause mortality
30 days after discharge, 6 months and 1 year after randomization
Non-lethal myocardial infarction
30 days after discharge, 6 months and 1 year after randomization
Severe recurrent ischemia
30 days after discharge, 6 months and 1 year after randomization
Stroke
30 days after discharge, 6 months and 1 year after randomization
- +1 more secondary outcomes
Study Arms (2)
Early invasive strategy
ACTIVE COMPARATORPatients 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.
Deferred invasive strategy
EXPERIMENTALPatients undergo coronary angiography and appropriate revascularization after at lest 72 hours from admission in the index hospitalization.
Interventions
Routine coronary angiography and revascularization if appropriate within 24 hours
Routine coronary angiography and revascularization if appropriate after 72 hours
Eligibility Criteria
You may qualify if:
- Aged 75 years or older
- Elevated cardiac troponin;
- Ischemic symptom or ST-segment depression in ECG；
- Newly onset of myocardial ischemia within 24 hours;
- Written Informed Consent obtained.
You may not qualify if:
- Type 2 MI (secondary to tachyarrhythmias, uncontrolled hypertension, anemia, hyperthyroidism, acute pulmonary infection, or fever)
- Secondary elevation of cardiac troponin (e.g. renal insufficiency, heart failure, et al.)
- Persistent ST-segment elevation or new pathologic Q wave indicating STEMI
- Ongoing myocardial ischemia despite intensive medical treatment after admission
- Refractory acute heart failure that can not be well controlled despite treatment for 24 hours
- Hemodynamic instability or cardiac shock on admission
- History of cardiac arrest or ventricular tachycardia/fibrillation after symptom onset
- Concomitant use of oral anticoagulants for atrial fibrillation or thromboembolism diseases
- PCI or bypass surgery within 30 days before randomization
- History of contrast agent allergy
- Baseline serum creatinine of \>2.5 mg/dl or calculated creatinine clearance rate of \<30 ml/min
- Known bleeding diathesis or contraindications to dual antiplatelet treatment like active internal bleeding
- Gastrointestinal and genitourinary bleeding of clinical significance within 6 weeks before randomization
- History of stroke within 3 months
- infectious diseases or fever
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fuwai Hospital
Beijing, Beijing Municipality, 100037, China
Related Publications (1)
Leng WX, Yang J, Li W, Wang Y, Yang YJ; DEAR-OLD investigators. Rationale and design of the DEAR-OLD trial: Randomized evaluation of routinely Deferred versus EARly invasive strategy in elderly patients of 75 years or OLDer with non-ST-elevation myocardial infarction. Am Heart J. 2018 Feb;196:65-73. doi: 10.1016/j.ahj.2017.10.022. Epub 2017 Nov 5.
PMID: 29421016DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yuejin Yang, M.D., PhD.
National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Fuwai Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- vice president of Fuwai Hospital
Study Record Dates
First Submitted
August 24, 2016
First Posted
September 14, 2016
Study Start
December 1, 2016
Primary Completion
October 30, 2019
Study Completion
October 30, 2019
Last Updated
October 3, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share