Direct Complete Versus Staged Complete Revascularization in Patients Presenting With Acute Corona… (NCT03621501) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Direct Complete Versus Staged Complete Revascularization in Patients Presenting With Acute Coronary Syndromes and Multivessel Disease
Netherlands1,525 participantsStarted 2018-06-22
Plain-language summary
To test whether immediate complete revascularization is non-inferior to staged (but within six weeks after index procedure) complete revascularization in Patients presenting with ACS, including Non-ST-elevation ACS (NSTEACS) and ST-elevation myocardial infarction (STEMI), with multivessel disease accepted for PCI
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Inclusion criteria STEMI-ACS ST-segment elevation myocardial infarction (STEMI) Both criteria must be present for eligibility
* Chest pain for more than 20 minutes with an electrocardiographic ST-segment elevation of 1 mm or greater in two or more contiguous leads, or with a new left bundle-branch block
* Admission either within 12 hours of symptom onset or between 12 and 24 hours after onset with evidence of continuing ischemia.
Inclusion criteria for NSTE-ACS Non-ST-segment elevation myocardial infarction (NSTEMI) At least two of the following must be present for eligibility
* History consistent with new, or worsening ischemia, occurring at rest or with minimal activity
* Coronary angiography with indication to PCI
* Troponin T or I or creatine kinase MB above the upper limit of normal
* Electrocardiographic changes compatible with ischemia but not diagnostic for ST-segment elevation myocardial infarction (i.e. ST depression of 1 mm or greater in two contiguous leads, T-wave inversion more than 3 mm, or any dynamic ST shifts) 0 Unstable Angina (UA)
At least two of the following must be present in the absence of cardiomyocyte necrosis (i.e. Troponin T or I and creatine kinase MB must be within normal limits):
* History consistent with new, or worsening ischemia, occurring at rest or with minimal activity
* Coronary angiography with indication to PCI
* Electrocardiographic changes compatible with ischemia but not diagnostic for ST-segment elevation m…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.