NCT04752345

Brief 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
632

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

February 9, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 12, 2021

Completed
17 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

February 12, 2021

Status Verified

January 1, 2021

Enrollment Period

1.5 years

First QC Date

February 9, 2021

Last Update Submit

February 10, 2021

Conditions

ST Elevation Myocardial Infarction

Keywords

ST-elevation myocardial infarctionprimary percutaneous coronarypharmacoinvasive strategyreduced-dose fibrinolysis

Outcome Measures

Primary Outcomes (1)

  • The rate of major composite endpoint events

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

    30 days

Secondary Outcomes (13)

  • The rate of major ventricular arrhythmia

    1 year

  • The rate of ischemia stroke

    1 year

  • The rate of death

    1 year

  • The rate of reinfarction

    1 year

  • The rate of stent thrombosis

    1 year

  • +8 more secondary outcomes

Other Outcomes (2)

  • Cost-effectiveness of reduced-dose pharmacoinvasive strategy compared to current care

    1 year

  • Health-related quality of life

    1 year

Study Arms (2)

Control group

ACTIVE COMPARATOR

Pharmacoinvasive strategy, fibrinolysis combined with rescue PCI (in case of failed fibrinolysis) or routine early invasive strategy (in case of successful fibrinolysis)

Other: Pharmacoinvasive strategy

Experimental group

EXPERIMENTAL

Reduced-dose fibrinolysis combined with immediate invasive therapy

Other: Reduced-dose facilitated PCI strategy

Interventions

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)

Control group
Reduced-dose facilitated PCI strategyOTHER

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

Experimental group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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);
  • 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;
  • Pregnant or lactating;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 33634478DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Yong He

    Department of Cardiology, West China Hospital of Sichuan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong He

CONTACT

+86 13981919366heyong_huaxi@163.com

Zhongxiu Chen

CONTACT

+86 18030708238619087296@qq.com

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
Professor

Study Record Dates

First Submitted

February 9, 2021

First Posted

February 12, 2021

Study Start

March 1, 2021

Primary Completion

September 1, 2022

Study Completion

September 1, 2023

Last Updated

February 12, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

IPD will be shared within six months after the trial finished through Electronic data capture system or ResMan

Shared Documents
STUDY PROTOCOL
Time Frame
Within six months after the trial complete