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ST Elevation Myocardial InfarctionNCT04752345

Optimal Reperfusion Strategy for STEMI Patients With Anticipated PPCI Delay

A study testing Pharmacoinvasive strategy and Reduced-dose facilitated PCI strategy in people with ST Elevation Myocardial Infarction, run by West China Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The OPTIMAL-REPERFUSION trial will help determine whether reduced-dose facilitated PCI strategy improves clinical outcomes in patients with STEMI and anticipated PPCI delay Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
ST Elevation Myocardial Infarction
What is being tested?
Pharmacoinvasive strategy and Reduced-dose facilitated PCI strategy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
632 participants
Where
No sites listed yet
Study dates
Mar 2021to Sep 2023
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

  • Aged 18 or over and less than 75 years old;
  • Patents with STEMI with symptom onset persisted more than 30mim and within 6 h before randomization;
  • ECG >=2 mm ST-segment elevation in 2 contiguous precordial leads or >=1 mm ST- segment elevation in 2 contiguous extremity leads, or new left bundle branch block;
  • Patents with an expected time from FMC to PCI >=120 min.
  • Signed informed consent form prior to trial participation.

Who cannot join

  • Fibrinolysis contradictions: Definite hemorrhagic stroke history;ischemic stroke or cerebrovascular accident in nearly 6 months;
  • Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) or recent trauma to the head or cranium (i.e. < 3 months);
  • Active bleeding or known bleeding disorder/diathesis; Recent administration of any i.v. or s.c. anticoagulation within 12 hours including unfractionated heparin, enoxaparin and/or bivalirudin or current use of oral anticoagulation (warfarin or coumadin);
  • Arterial aneurysm, arterial/venous malformation and aorta dissection; Uncontrolled hypertension, defined as a single blood pressure measurement >=180/110 mm Hg (systolic BP >=180 mm Hg and/or diastolic BP >=110 mm Hg) prior to randomisation;
  • Major surgery, biopsy of a parenchymal organ, noncompressible vascular puncture, or significant trauma within the past 2 months (this includes any trauma associated with the current myocardial infarction);
  • prolonged or traumatic cardiopulmonary resuscitation (> 10 minutes) within the past 2 weeks; major surgery pending in the following 30 days. 2. Complex heart condition Evidence of cardiac rupture; Pre-existing heart failure and previous New York heart function classification III-IVCardiogenic shock (SBP <90mmHg after fluid infusion or SBP<100mmHg after vasoactive drugs);
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  • PCI within previous 1 month or previous bypass surgery;
  • Myocardial infarction in the past year or previously known coronary artery disease not suitable for revascularization;
  • Known acute pericarditis and/or subacute bacterial endocarditis;
  • Hospitalization for cardiac reason within past 48 hours;
  • Severe comorbidity: Other diseases with life expectancy <=12 months;
  • Any history of severe renal or hepatic dysfunction (hepatic failure, cirrhosis, portal hypertension or active hepatitis);
  • neutropenia, thrombocytopenia;
  • Severe COPD with hypoxemia;
  • Not suitable for clinical trial: Inclusion in another clinical trial; Previous enrollment in this study or treatment with an investigational drug or device under another study protocol in the past 7 days;
  • Pregnant or lactating;
  • Body weight <40kg;
  • Known hypersensitivity to any drug that may be used in the study;
  • Inability to follow the protocol and comply with follow-up requirements or any other reason the investigator feels would place the patient at increased risk.

Trial locations and contacts

No sites are listed yet.

Yong He contact

+86 13981919366

heyong_huaxi@163.com

Zhongxiu Chen contact

+86 18030708238

619087296@qq.com

About this study

Official title: A Prospective Randomized Multi-center Clinical Trial Comparing Different Fibrinolysis-transfer Percutaneous Coronary Intervention Strategies in Acute ST-segment Elevation Myocardial Infarction

The OPTIMAL-REPERFUSION trial will help determine whether reduced-dose facilitated PCI strategy improves clinical outcomes in patients with STEMI and anticipated PPCI delay

Read the detailed description

OPTIMAL-REPERFUSION is an investigator-initiated, prospective, multicenter, randomized, open-label, superiority trial with blinded evaluation of outcomes. A total of 632 STEMI patients presenting within 6 hours after symptom onset and with an expected time of medical contact to percutaneous coronary intervention ≥120 min will be randomized to a reduced-dose facilitated PCI strategy (reduced-dose fibrinolysis combined with simultaneous transfer for immediate invasive therapy with a time interval between fibrinolysis to PCI < 3 hours) or to pharmacoinvasive treatment. The primary endpoint is the composite of death, reinfarction, refractory ischemia, congestive heart failure, or cardiogenic shock at 30-days.

Being tested
Pharmacoinvasive strategy, Reduced-dose facilitated PCI strategy
Keywords
ST-elevation myocardial infarction, primary percutaneous coronary, pharmacoinvasive strategy, reduced-dose fibrinolysis
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.

  • Pharmacoinvasive strategyOther

    Pharmacoinvasive treatment [full-dose fibrinolysis combined with rescue PCI (in case of failed fibrinolysis) or routine early PCI (3 to 24 hours, in case of successful fibrinolysis)

  • Reduced-dose facilitated PCI strategyOther

    Reduced-dose facilitated PCI[reduced-dose fibrinolysis,simultaneously transfer,immediate coronary angiography and andioplasty when arrived at PCI center(<3 hours)]

Study groups in NCT04752345
Study groupRoleWhat they receive
Control groupActive comparatorPharmacoinvasive strategy, fibrinolysis combined with rescue PCI (in case of failed fibrinolysis) or routine early invasive strategy (in case of successful fibrinolysis)
Receives: Other: Pharmacoinvasive strategy
Experimental groupExperimentalReduced-dose fibrinolysis combined with immediate invasive therapy
Receives: Other: Reduced-dose facilitated PCI strategy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The rate of major composite endpoint events

    Composite of death, reinfarction, refractory ischaemia, congestive heart failure, or cardiogenic shock

    Measured: 30 days

Secondary outcomes (13)

  1. The rate of major ventricular arrhythmia

    Ventricular arrhythmias, occurring more than 6 hours after randomization, persisting for at least 30 seconds, and accompanying with unstable hemodynamics that required electrical cardioversion / defibrillation

    Measured: 1 year

  2. The rate of ischemia stroke

    Defined as the presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting more than 24 hours. It is strongly recommended (but not required) that an imaging procedure such as a computerized tomography (CT) or magnetic resonance imaging (MRI) be performed.

    Measured: 1 year

  3. The rate of death

    Death will be classified as cardiovascular or non-cardiovascular.

    Measured: 1 year

  4. The rate of reinfarction

    Recurrent symptoms or signs of cardiac ischemia lasting more than 30 minutes with new ST-T segment changes or Q-wave in at least 2 contiguous leads or new onset LBBB and recurrent significant increase in cardiac enzyme levels. The increase in CK-MB level is considered significant when it occurs after at least a ≥25% decrease in CK-MB from a prior peak level and is >2 times the upper limit of normal (ULN) in the absence of coronary interventions, or >5 times above the ULN after PCI

    Measured: 1 year

  5. The rate of stent thrombosis

    The stent thrombosis are defined in accordance with the Academic Research Consortium (ARC) definitions

    Measured: 1 year

  6. The rate of target vessel revascularization

    The target vessel revascularizationare defined in accordance with the Academic Research Consortium (ARC) definitions

    Measured: 1year

  7. The rate of congestive heart failure

    New or worsening congestive heart failure will be considered as patients presenting with at least one of the following conditions and requiring treatment with diuretics: 1) Pulmonary oedema/congestion on chest X-ray without suspicion of a non-cardiac cause; 2) Rales >1/3 up from the lung base; 3) Pulmonary capillary wedge pressure (PCWP) >25 mmHg; 4) Dyspnea with PO2 < 80 mmHg or O2 sat < 90 % (no supplemental O2) in the absence of known lung disease.

    Measured: 1 year

  8. The rate of Cardiogenic shock

    The manifestation of vascular collapse and shock (systolic BP < 90 mmHg for at least 30 min or systolic BP > 90 mmHg after inotropic or intra-aortic balloon support with a cardiac index < 2.2 L/min/m2 or < 2.5 L/min/m2 after inotropic or intra-aortic balloon support, peripheral signs of hypoperfusion, and chest X-ray with pulmonary edema

    Measured: 1 year

  9. Number of Participants with TIMI flow grade (TFG) 3 for epicardial reperfusion

    TIMI flow grade (TFG) 3 for epicardial reperfusion

    Measured: 1 minute after stent was deployed

  10. Number of Participants with TIMI myocardial perfusion grade (TMPG) 3 for myocardial reperfusion

    TIMI myocardial perfusion grade (TMPG) 3 for myocardial reperfusion

    Measured: 1 minute after stent was deployed

  11. Resolution of the initial sum of ST- segment elevation (STR) ≥ 70% post catheterization

    Resolution of the initial sum of ST- segment elevation (STR) ≥ 70% post catheterization

    Measured: 60min after the stent was deployed

  12. Peak CK-MB level

    Peak CK-MB level

    Measured: 48 hours after system onset

  13. Adverse events

    Intracranial bleeding or major bleeding

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2021
  2. Study startMar 2021 (estimated)
  3. Primary completionSep 2022 (estimated)
  4. Study completionSep 2023 (estimated)

Resources

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
632 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04752345
Sponsor's protocol ID
WestChinaH-CVD-002
Status last verified
Jan 2021
First submitted
9 Feb 2021
Last updated
12 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD will be shared within six months after the trial finished through Electronic data capture system or ResMan

Publications

  • Chen Z, Wang D, Ma M, Li C, Wan Z, Zhang L, Zhu Y, Wang M, Wang H, He S, Peng Y, Wei J, Huang B, He Y; OPTIMAL-REPERFUSION trial investigator. Rationale and design of the OPTIMAL-REPERFUSION trial: A prospective randomized multi-center clinical trial comparing different fibrinolysis-transfer percutaneous coronary intervention strategies in acute ST-segment elevation myocardial infarction. Clin Cardiol. 2021 Apr;44(4):455-462. doi: 10.1002/clc.23582. Epub 2021 Feb 25.

    PubMed 33634478

Questions about this trial

What is this clinical trial studying?

A study testing Pharmacoinvasive strategy and Reduced-dose facilitated PCI strategy in people with ST Elevation Myocardial Infarction, run by West China 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 5 inclusion and 19 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 12 Feb 2021. 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 Yong He (+86 13981919366, heyong_huaxi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of major composite endpoint events (time frame: 30 days). 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 NCT04752345, which also lists 1 linked publication.

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 12 Feb 2021.

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