ST-segment Elevation Myocardial Infarction (STEMI)NCT04575012
Compare Early With Deferred Invasive Strategy for STEMI Presenting 24-48 Hours From Symptom Onset
A study testing Deferred invasive strategy and Early invasive strategy in people with ST-segment Elevation Myocardial Infarction (STEMI), run by Shanghai Zhongshan Hospital.
Trial summary
The primary objective of the trial is to compare the efficacy of early with deferred invasive strategy for patients with ST-segment elevation myocardial infarction (STEMI) within 24-48h of symptom onset. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ST-segment Elevation Myocardial Infarction (STEMI)
- What is being tested?
- Deferred invasive strategy and Early invasive strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 or over and less than 75 years old;
- ECG: ≥2 mm ST-segment elevation in 2 contiguous precordial leads or ≥1 mm ST-segment elevation in 2 contiguous extremity leads;
- Patents with STEMI with symptom onset between 24 and 48 hours before randomization;
- Signed informed consent form prior to trial participation.
Who cannot join
- Patents with STEMI with symptom onset <24h or >48h or uncertain time onset;
- Prior administration of thrombolytic therapy or attempted PCI before randomization;
- Presence of indications for primary PCI, such as persistent chest pain, cardiogenic shock, life-threatening arrhythmias or cardiac arrest, severe acute heart failure, and mechanical complications;
- Coagulopathy, active peptic ulcer, history of cerebral or subarachnoid hemorrhage, stroke within 6 months, other contraindications for antiplatelet or anticoagulant therapy;
- Known intolerance to antiplatelet (e.g. aspirin, clopidogrel, ticagrelor) and anticoagulant therapy (e.g. heparin, bivalirudin);
- Congenital heart disease or severe valvular disease;
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- eGFR <30 ml/min/1.73 m2;
- History of malignant tumors;
- Combined with other diseases and life expectancy ≤12 months;
- Pregnancy;
- Inclusion in another clinical trial;
- Inability to provide informed consent or not available for follow-up judged by investigator.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Multicentre Trial to Compare Early With Deferred Invasive Strategy for Patients With Acute ST-segment Elevation Myocardial Infarction Presenting 24-48 Hours From Symptom Onset
The primary objective of the trial is to compare the efficacy of early with deferred invasive strategy for patients with ST-segment elevation myocardial infarction (STEMI) within 24-48h of symptom onset.
Read the detailed description
At present, timely primary percutaneous coronary intervention (PCI) is the preferred strategy for STEMI patients within 24h of symptom onset. In stable STEMI patients presenting 12 to 48 hours from symptom onset, BRAVE-2 Trial (n = 365) showed improved myocardial salvage and 4-year survival in patients treated with primary PCI compared with conservative treatment alone. However, data is scarce about the reperfusion strategy focusing on STEMI patients within 24-48h of symptom onset.
To our knowledge, due to the long onset time and insufficient antiplatelet/anticoagulant treatment, infarct-related artery in STEMI patients beyond 24h of symptom onset frequently suffer from severer thrombus burden. In this situation, the risk of no-reflow in primary PCI is high. Meanwhile, myocardial coagulative necrosis would be fully developed during 24-72h from symptom onset, the risk of perioperative cardiac rupture may also rise. These bring some doubts about the benefits of early invasive strategy for STEMI patients within 24-48h of symptom onset. Further investigations are warranted to explore the best timing of invasive strategy for STEMI patients within 24-48h of symptom onset.
Given that no randomized clinical trial is designed especially for STEMI patients within 24-48h of symptom onset, and limited data is available to compare early with deferred invasive strategy for the subgroup of STEMI patients, investigators plan to perform a controlled, randomized trial to compare the efficacy of early with deferred invasive strategy for STEMI patients within 24-48h of symptom onset.
- Being tested
- Deferred invasive strategy, Early invasive strategy
- Keywords
- ST-segment Elevation Myocardial Infarction, Percutaneous Coronary Intervention, Invasive Strategy
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deferred invasive strategyProcedure or surgery
PCI on 7 to 10 days after symptom onset
Early invasive strategyProcedure or surgery
Primary PCI
| Study group | Role | What they receive |
|---|---|---|
| Deferred invasive strategy | Experimental | Not described Receives: Procedure: Deferred invasive strategy |
| Early invasive strategy | Other | Not described Receives: Procedure: Early invasive strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite of death from any cause, recurrent myocardial infarction, ischaemia-driven target vessel revascularization, or hospitalization due to NYHA class IV heart failure
Measured: 4 years
Secondary outcomes (7)
No-reflow in infarct-related artery
The definition of no-reflow was Thrombolysis In Myocardial Infarction (TIMI) flow grade ≤ 2 on the final angiogram in a coronary angiographic analysis.
Measured: Immediately after PCI
Major adverse cardiac events (defined as a composite of cardiac death, recurrent myocardial infarction, or ischaemia-driven target vessel revascularization)
Measured: 30 days
Stroke
The diagnosis of stroke required confirmation by computed tomography or magnetic resonance imaging of the head in the presence of a new onset focal or global neurological deficit lasting more than 24 hours.
Measured: 30 days
Death from any cause
Measured: 4 years
Recurrent myocardial infarction
Measured: 4 years
Ischaemia-driven target vessel revascularization
Measured: 4 years
Hospitalization due to NYHA class IV heart failure
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST-segment Elevation Myocardial Infarction (STEMI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junbo Ge, M.D., Principal investigator, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575012
- Sponsor's protocol ID
- ZS-STEMI 24-48
- Status last verified
- Sep 2020
- First submitted
- 26 Sep 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Multicentre Trial to Compare Early With Deferred Invasive Strategy for Patients With Acute ST-segment Elevation Myocardial Infarction Presenting 24-48 Hours From Symptom Onset
- ClinicalTrials.gov ID
- NCT04575012
- Acronym / sponsor ID
- ZS-STEMI 24-48
- Keywords
- ST-segment Elevation Myocardial Infarction, Percutaneous Coronary Intervention, Invasive Strategy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the trial is to compare the efficacy of early with deferred invasive strategy for patients with ST-segment elevation myocardial infarction (STEMI) within 24-48h of symptom onset.
Detailed description
At present, timely primary percutaneous coronary intervention (PCI) is the preferred strategy for STEMI patients within 24h of symptom onset. In stable STEMI patients presenting 12 to 48 hours from symptom onset, BRAVE-2 Trial (n = 365) showed improved myocardial salvage and 4-year survival in patients treated with primary PCI compared with conservative treatment alone. However, data is scarce about the reperfusion strategy focusing on STEMI patients within 24-48h of symptom onset.
To our knowledge, due to the long onset time and insufficient antiplatelet/anticoagulant treatment, infarct-related artery in STEMI patients beyond 24h of symptom onset frequently suffer from severer thrombus burden. In this situation, the risk of no-reflow in primary PCI is high. Meanwhile, myocardial coagulative necrosis would be fully developed during 24-72h from symptom onset, the risk of perioperative cardiac rupture may also rise. These bring some doubts about the benefits of early invasive strategy for STEMI patients within 24-48h of symptom onset. Further investigations are warranted to explore the best timing of invasive strategy for STEMI patients within 24-48h of symptom onset.
Given that no randomized clinical trial is designed especially for STEMI patients within 24-48h of symptom onset, and limited data is available to compare early with deferred invasive strategy for the subgroup of STEMI patients, investigators plan to perform a controlled, randomized trial to compare the efficacy of early with deferred invasive strategy for STEMI patients within 24-48h of symptom onset.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deferred invasive strategy | Experimental | Procedure: Deferred invasive strategy |
| Early invasive strategy | Other | Procedure: Early invasive strategy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18 or over and less than 75 years old;
- ECG: ≥2 mm ST-segment elevation in 2 contiguous precordial leads or ≥1 mm ST-segment elevation in 2 contiguous extremity leads;
- Patents with STEMI with symptom onset between 24 and 48 hours before randomization;
- Signed informed consent form prior to trial participation.
Key exclusion criteria (12 listed)
- Patents with STEMI with symptom onset <24h or >48h or uncertain time onset;
- Prior administration of thrombolytic therapy or attempted PCI before randomization;
- Presence of indications for primary PCI, such as persistent chest pain, cardiogenic shock, life-threatening arrhythmias or cardiac arrest, severe acute heart failure, and mechanical complications;
- Coagulopathy, active peptic ulcer, history of cerebral or subarachnoid hemorrhage, stroke within 6 months, other contraindications for antiplatelet or anticoagulant therapy;
- Known intolerance to antiplatelet (e.g. aspirin, clopidogrel, ticagrelor) and anticoagulant therapy (e.g. heparin, bivalirudin);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deferred invasive strategyPCI on 7 to 10 days after symptom onset | Procedure or surgery | Deferred invasive strategy |
| Early invasive strategyPrimary PCI | Procedure or surgery | Early invasive strategy |
Primary outcome
A composite of death from any cause, recurrent myocardial infarction, ischaemia-driven target vessel revascularization, or hospitalization due to NYHA class IV heart failure
Time frame: 4 years
7 secondary outcomes
No-reflow in infarct-related artery
Time frame: Immediately after PCI
Major adverse cardiac events (defined as a composite of cardiac death, recurrent myocardial infarction, or ischaemia-driven target vessel revascularization)
Time frame: 30 days
Stroke
Time frame: 30 days
Death from any cause
Time frame: 4 years
Recurrent myocardial infarction
Time frame: 4 years
Ischaemia-driven target vessel revascularization
Time frame: 4 years
Hospitalization due to NYHA class IV heart failure
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Individual participant dataSharing planned: No
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Integrated Assessment of Immune-Inflammatory and Metabolic Biomarkers for Prediction of Coronary No-Reflow Following Primary PCI in STEMI Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junbo Ge, M.D. principal investigator
Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University
Questions about this trial
What is this clinical trial studying?
A study testing Deferred invasive strategy and Early invasive strategy in people with ST-segment Elevation Myocardial Infarction (STEMI), run by Shanghai Zhongshan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Zhong, M.D. (+86 13585678706, zhong.xin@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite of death from any cause, recurrent myocardial infarction, ischaemia-driven target vessel revascularization, or hospitalization due to NYHA class IV heart failure (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.