Acute Coronary SyndromeNCT02750579
Early or Delayed Revascularization for Intermediate and High-risk Non ST-elevation Acute Coronary Syndromes?
A study testing Percutaneous coronary intervention for revascularization in people with Acute Coronary Syndrome, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Percutaneous coronary intervention (PCI) is the cornerstone of the care of intermediate and high-risk non ST-elevation acute coronary syndromes (NSTE ACS). Revascularization reduces the rate of cardiovascular death and recurrent myocardial infarction in this clinical setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Percutaneous coronary intervention for revascularization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 740 participants
- Where
- 1 siteFrance
- Study dates
- 5 Sep 2016to Apr 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must not be of child-bearing potential (1 year post-menopausal, contraceptive use or surgically sterile);
- Subject with a non-ST-segment elevation ACS defined by the presence of at least 2 of the following criteria: symptoms of myocardial ischemia, electrocardiographic ST-segment abnormalities (depression or transient elevation of at least 0.1 mV) or T-wave inversion in at least in 2 contiguous leads, or an elevated cardiac troponin value (above the upper limit of normal) ;
- Subject requiring intervention according to physician's judgment including the following criteria subject with one of the following risk factor defining intermediate and high risk ACS: diabetes mellitus, kidney failure, reduced LVEF, early post infarction angina, recent PCI, prior CABG or a GRACE risk score >109, recurrent symptoms or ischaemia on non-invasive testing (2);
- Must be enrolled at a cardiac catheterization laboratory hospital or at a hospital/ambulance service affiliated with a cardiac catheterization laboratory hospital;
Who cannot join
- - Minors or pregnant or breast-feeding women;
- Subject with low risk ACS;
- Subject with very high-risk ACS: refractory angina, severe heart failure, life-threatening ventricular arrhythmias, hemodynamic instability requiring immediate intervention;
- Subject with thrombolytic therapy during the preceding 24 hours;
- Subject with bleeding diathesis;
- Subject with Upstream treatment by a GPIIb/IIIa inhibitor;
Show all 17Show fewer
- Subject under chronic anticoagulant;
- Subject participating in another research protocol;
- Subject not agreeing to participate;
- Subject with contraindication to or under chronic P2Y12 receptor antagonists therapy (clopidogrel, ticagrelor and prasugrel);
- Present with ST-segment elevation myocardial infarction (STEMI) at the time of entry or randomization into the study defined as follows:
- ST-segment elevation myocardial infarction is defined as a history of chest discomfort or ischemic symptoms of >20 minutes duration at rest ≤14 days prior to entry into the study with one of the following present on at least one ECG prior to randomization:
- ST-segment elevation ≥1 mm in two or more contiguous ECG leads.
- New or presumably new left bundle branch block (LBBB).
- ST-segment depression ≥1 mm in two anterior precordial leads (V1 through V4) with clinical history and evidence suggestive of true posterior infarction.
- Have cardiogenic shock (systolic blood pressure <90 mm Hg associated with clinical evidence of end-organ hypoperfusion, or subjects requiring vasopressors to maintain systolic blood pressure over 90 mm Hg and associated with clinical evidence of end-organ hypoperfusion);
- Have New York Heart Association (NYHA) Class IV congestive heart failure (CHF).
Trial locations and contacts
1 site in 1 country.
About this study
Percutaneous coronary intervention (PCI) is the cornerstone of the care of intermediate and high-risk non ST-elevation acute coronary syndromes (NSTE ACS). Revascularization reduces the rate of cardiovascular death and recurrent myocardial infarction in this clinical setting. The recommendation regarding the timing of intervention in this clinical setting is derived from old trials and has a weak level of evidence. In fact, there are no conclusive randomized trials in the contemporary era providing guidance on the optimal timing of intervention. In addition, the optimal timing of this critical intervention has not been studied since the development of new P2Y12-ADP receptor antagonists and the controversy surrounding the use of pretreatment with a P2Y12-ADP receptor antagonist before intervention. Early intervention in intermediate and high-risk non ST-elevation ACS is not well validated to date. In addition, the recent changes in the use of pretreatment with P2Y12-ADP receptor antagonists may impact on the potential benefit of an early intervention.
Based on these evidences, we hypothesize that with the current protocols of care without pretreatment with a P2Y12-ADP receptor antagonist, an early PCI (<2 hours) would be superior to a delayed (between 12 to 72 hours) PCI in the setting of intermediate or high-risk non-ST elevation acute coronary syndrome to prevent cardiovascular death and ischemic recurrences.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Percutaneous coronary intervention for revascularization
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary intervention for revascularizationProcedure or surgery
Percutaneous coronary intervention for revascularization with anticoagulant and antiplatelet therapy (routine care)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | control group: Percutaneous coronary intervention for revascularization delayed intervention (12 to 72 hours) Receives: Procedure: Percutaneous coronary intervention for revascularization |
| experimental group | Experimental | experimental group: early Percutaneous coronary intervention for revascularization intervention (<2 hours) Receives: Procedure: Percutaneous coronary intervention for revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrent ischemic events
compare the efficacy defined by the rate of recurrent ischemic events at 1 month of 2 therapeutic strategies: an immediate (<2 hours) versus a delayed (12-72 hours) intervention for intermediate and high-risk non ST-elevation acute coronary syndrome compare the efficacy defined by the rate of cardiovascular death and/or recurrent ischemic events at 1 month of 2 therapeutic strategies: an immediate (<2 hours) versus a delayed (12-72 hours) intervention for intermediate and high-risk non ST-elevation acute coronary syndrome
Measured: 1 month
cardiovascular death
compare the efficacy defined by the rate of cardiovascular death at 1 month of 2 therapeutic strategies: an immediate (<2 hours) versus a delayed (12-72 hours) intervention for intermediate and high-risk non ST-elevation acute coronary syndrome
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study start5 Sep 2016
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 740 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Bonello, MD, Principal investigator, assistance Public Hopitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750579
- Sponsor's protocol ID
- 2016-A00379-42
- Status last verified
- Apr 2018
- First submitted
- 21 Apr 2016
- Last updated
- 9 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lemesle G, Laine M, Pankert M, Boueri Z, Motreff P, Paganelli F, Baumstarck K, Roch A, Kerbaul F, Puymirat E, Bonello L. Optimal Timing of Intervention in NSTE-ACS Without Pre-Treatment: The EARLY Randomized Trial. JACC Cardiovasc Interv. 2020 Apr 27;13(8):907-917. doi: 10.1016/j.jcin.2020.01.231.
PubMed 32327087Lemesle G, Laine M, Pankert M, Puymirat E, Bonello L. Great expectations. Lancet. 2018 Jan 27;391(10118):306. doi: 10.1016/S0140-6736(18)30096-5. Epub 2018 Jan 31. No abstract available.
PubMed 29413039
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early or Delayed Revascularization for Intermediate and High-risk Non ST-elevation Acute Coronary Syndromes?
- ClinicalTrials.gov ID
- NCT02750579
- Acronym / sponsor ID
- 2016-A00379-42
- Conditions
- Acute Coronary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 740 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 5 Sep 2016 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 25 Apr 2016 (estimated)
- 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.
Percutaneous coronary intervention (PCI) is the cornerstone of the care of intermediate and high-risk non ST-elevation acute coronary syndromes (NSTE ACS). Revascularization reduces the rate of cardiovascular death and recurrent myocardial infarction in this clinical setting. The recommendation regarding the timing of intervention in this clinical setting is derived from old trials and has a weak level of evidence. In fact, there are no conclusive randomized trials in the contemporary era providing guidance on the optimal timing of intervention. In addition, the optimal timing of this critical intervention has not been studied since the development of new P2Y12-ADP receptor antagonists and the controversy surrounding the use of pretreatment with a P2Y12-ADP receptor antagonist before intervention. Early intervention in intermediate and high-risk non ST-elevation ACS is not well validated to date. In addition, the recent changes in the use of pretreatment with P2Y12-ADP receptor antagonists may impact on the potential benefit of an early intervention.
Based on these evidences, we hypothesize that with the current protocols of care without pretreatment with a P2Y12-ADP receptor antagonist, an early PCI (<2 hours) would be superior to a delayed (between 12 to 72 hours) PCI in the setting of intermediate or high-risk non-ST elevation acute coronary syndrome to prevent cardiovascular death and ischemic recurrences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Percutaneous coronary intervention for revascularizationcontrol group: Percutaneous coronary intervention for revascularization delayed intervention (12 to 72 hours) |
| experimental group | Experimental | Procedure: Percutaneous coronary intervention for revascularizationexperimental group: early Percutaneous coronary intervention for revascularization intervention (<2 hours) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must not be of child-bearing potential (1 year post-menopausal, contraceptive use or surgically sterile);
- Subject with a non-ST-segment elevation ACS defined by the presence of at least 2 of the following criteria: symptoms of myocardial ischemia, electrocardiographic ST-segment abnormalities (depression or transient elevation of at least 0.1 mV) or T-wave inversion in at least in 2 contiguous leads, or an elevated cardiac troponin value (above the upper limit of normal) ;
- Subject requiring intervention according to physician's judgment including the following criteria subject with one of the following risk factor defining intermediate and high risk ACS: diabetes mellitus, kidney failure, reduced LVEF, early post infarction angina, recent PCI, prior CABG or a GRACE risk score >109, recurrent symptoms or ischaemia on non-invasive testing (2);
- Must be enrolled at a cardiac catheterization laboratory hospital or at a hospital/ambulance service affiliated with a cardiac catheterization laboratory hospital;
Key exclusion criteria (17 listed)
- - Minors or pregnant or breast-feeding women;
- Subject with low risk ACS;
- Subject with very high-risk ACS: refractory angina, severe heart failure, life-threatening ventricular arrhythmias, hemodynamic instability requiring immediate intervention;
- Subject with thrombolytic therapy during the preceding 24 hours;
- Subject with bleeding diathesis;
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 |
|---|---|---|
| Percutaneous coronary intervention for revascularizationPercutaneous coronary intervention for revascularization with anticoagulant and antiplatelet therapy (routine care) | Procedure or surgery | Control group, experimental group |
Primary outcome
recurrent ischemic events
Time frame: 1 month
compare the efficacy defined by the rate of recurrent ischemic events at 1 month of 2 therapeutic strategies: an immediate (<2 hours) versus a delayed (12-72 hours) intervention for intermediate and high-risk non ST-elevation acute coronary syndrome compare the efficacy defined by the rate of cardiovascular death and/or recurrent ischemic events at 1 month of 2 therapeutic strategies: an immediate (<2 hours) versus a delayed (12-72 hours) intervention for intermediate and high-risk non ST-elevation acute coronary syndrome
cardiovascular death
Time frame: 1 month
compare the efficacy defined by the rate of cardiovascular death at 1 month of 2 therapeutic strategies: an immediate (<2 hours) versus a delayed (12-72 hours) intervention for intermediate and high-risk non ST-elevation acute coronary syndrome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
- Derived from this study: PubMed 32327087Lemesle G, Laine M, Pankert M, Boueri Z, Motreff P, Paganelli F, Baumstarck K, Roch A, Kerbaul F, Puymirat E, Bonello L. Optimal Timing of Intervention in NSTE-ACS Without Pre-Treatment: The EARLY Randomized Trial. JACC Cardiovasc Interv. 2020 Apr 27;13(8):907-917. doi: 10.1016/j.jcin.2020.01.231.
- Derived from this study: PubMed 29413039Lemesle G, Laine M, Pankert M, Puymirat E, Bonello L. Great expectations. Lancet. 2018 Jan 27;391(10118):306. doi: 10.1016/S0140-6736(18)30096-5. Epub 2018 Jan 31. No abstract available.
- Individual participant dataSharing planned: No
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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.
Laurent Bonello, MD principal investigator
assistance Public Hopitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous coronary intervention for revascularization in people with Acute Coronary Syndrome, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 17 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: finished, as of the sponsor's last update on 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrent ischemic events (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02750579, which also lists 2 linked publications.
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 9 Apr 2018.