NCT04575012

Brief 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.

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
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2020

Longer than P75 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

September 26, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

October 5, 2020

Status Verified

September 1, 2020

Enrollment Period

2 years

First QC Date

September 26, 2020

Last Update Submit

September 29, 2020

Conditions

ST-segment Elevation Myocardial Infarction (STEMI)

Keywords

ST-segment Elevation Myocardial InfarctionPercutaneous Coronary InterventionInvasive Strategy

Outcome Measures

Primary Outcomes (1)

  • A composite of death from any cause, recurrent myocardial infarction, ischaemia-driven target vessel revascularization, or hospitalization due to NYHA class IV heart failure

    4 years

Secondary Outcomes (7)

  • No-reflow in infarct-related artery

    Immediately after PCI

  • Major adverse cardiac events (defined as a composite of cardiac death, recurrent myocardial infarction, or ischaemia-driven target vessel revascularization)

    30 days

  • Stroke

    30 days

  • Death from any cause

    4 years

  • Recurrent myocardial infarction

    4 years

  • +2 more secondary outcomes

Study Arms (2)

Deferred invasive strategy

EXPERIMENTAL
Procedure: Deferred invasive strategy

Early invasive strategy

OTHER
Procedure: Early invasive strategy

Interventions

Deferred invasive strategyPROCEDURE

PCI on 7 to 10 days after symptom onset

Deferred invasive strategy
Early invasive strategyPROCEDURE

Primary PCI

Early invasive strategy

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • eGFR \<30 ml/min/1.73 m2;
  • History of malignant tumors;
  • Combined with other diseases and life expectancy ≤12 months;
  • Pregnancy;
  • Inability to provide informed consent or not available for follow-up judged by investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Officials

  • Junbo Ge, M.D.

    Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Zhong, M.D.

CONTACT

+86 13585678706zhong.xin@zs-hospital.sh.cn

Wei Gao, M.D.

CONTACT

+86 13661959824gao.wei1@zs-hospital.sh.cn

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
SPONSOR

Study Record Dates

First Submitted

September 26, 2020

First Posted

October 5, 2020

Study Start

December 1, 2020

Primary Completion

December 1, 2022

Study Completion

December 1, 2025

Last Updated

October 5, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share