Immediate Versus Delayed Invasive Intervention for Non-STEMI Patients
RIDDLE-NSTEMI
Randomized Study of ImmeDiate Versus DeLayEd Invasive Intervention in Patients With Non ST-segment Elevation Myocardial Infarction
1 other identifier
interventional
323
1 country
1
Brief Summary
In patients with acute myocardial infarction without ST-segment elevation on ECG (non-STEMI), previous studies have indicated that routine invasive treatment confers more benefit as compared to selective invasive approach. The benefits of routine invasive coronary intervention have been the most evident in patients with higher baseline risk profile. However, the question of optimal timing of routine invasive intervention remains unsolved. Immediate invasive intervention early after admission for non-STEMI may limit myocardial necrosis by securing the patency of the culprit coronary artery. Nevertheless, several previous studies reported higher levels of biomarkers of myocardial injury in patients undergoing early PCI. The question of earlier versus delayed procedure in non-STEMI patients may thus amount to whether the risk of intervening on an unstable plaque is greater than the risk of new ischemic events while waiting for the invasive procedure. The purpose of the present study is to compare effects of immediate coronary intervention, within 2 hours of admission, versus delayed intervention, within 2-72 hours after admission, in patients witn non-STEMI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 9, 2015
CompletedFirst Posted
Study publicly available on registry
April 17, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedJuly 13, 2020
July 1, 2020
3.5 years
March 9, 2015
July 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite of all-cause death or myocardial reinfarction
within 30 days of randomization
Secondary Outcomes (7)
Composite of all-cause death, myocardial reinfarction or recurrent ischemia
within 30 days of randomization
All-cause mortality
within 30 days, 1, 3 and 5 years after randomization
Myocardial reinfarction
within 30 days, 1, 3 and 5 years after randomization
Stroke
within 30 days, 1, 3 and 5 years after randomization
Recurrent ischemia
within 30 days of randomization
- +2 more secondary outcomes
Study Arms (2)
Immediate invasive intervention
EXPERIMENTALInvasive coronary angiography followed by either percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery as soon as possible and/or within 2 hours of admission
Delayed invasive intervention
ACTIVE COMPARATORInvasive coronary angiography followed by either percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) surgery during the hospitalization and within 2-72 hours of admission
Interventions
Invasive coronary angiography followed by either percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) surgery as soon as possible and/or within 2 hours of admission
Invasive coronary angiography followed by either percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) surgery during the hospitalization and/or within 2-72 hours of admission
Implantation of coronary stents
Eligibility Criteria
You may qualify if:
- episode of chest pain occurring no longer than 24 hours prior to admission
- elevation of cardiac troponin I above the upper limit of normal (ULN)
- new ST-segment depression at least 1 millivolt (mV) and/or T-wave inversion or transient ST-segment elevation in ≥ 2 contiguous leads
You may not qualify if:
- age \< 18 years
- persistent ST-segment elevation
- hemodynamic instability
- cardiogenic shock on admission
- life-threatening ventricular arrhythmias on admission
- refractory angina on admission
- active bleeding
- any contraindication for the use of dual antiplatelet therapy (DAPT)
- presence of comorbidities with life expectancy \< 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Centre of Serbia, Department of Cardiology
Belgrade, 11000, Serbia
Related Publications (1)
Milosevic A, Vasiljevic-Pokrajcic Z, Milasinovic D, Marinkovic J, Vukcevic V, Stefanovic B, Asanin M, Dikic M, Stankovic S, Stankovic G. Immediate Versus Delayed Invasive Intervention for Non-STEMI Patients: The RIDDLE-NSTEMI Study. JACC Cardiovasc Interv. 2016 Mar 28;9(6):541-9. doi: 10.1016/j.jcin.2015.11.018. Epub 2016 Jan 6.
PMID: 26777321DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Goran Stankovic, MD, PhD
Clinical Centre of Serbia
- PRINCIPAL INVESTIGATOR
Aleksandra Milosevic, MD
Clinical Centre of Serbia
- STUDY CHAIR
Zorana Vasiljevic, MD, PhD
Clinical Centre of Serbia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 9, 2015
First Posted
April 17, 2015
Study Start
September 1, 2009
Primary Completion
March 1, 2013
Study Completion
March 1, 2018
Last Updated
July 13, 2020
Record last verified: 2020-07