Early Administration of Heparin At FMC for PPCI of STEMI Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-20

Study Completion Date

2024-08-20

Brief Summary

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Heparin is the first choice of anticoagulation drug for primary PCI of STEMI patients. However, the priority of use of hepairn in first medical contact or in Cathlab has not yet studied. Previous study revealed early use of antithrombotic drugs could improve patient's survival. Here we supposed that use of heparin at first medical contact could increase the TIMI flow 3 grade ratio in STEMI patients and improve patient's survival and/or reduce MACE rather than in Cathlab.

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Detailed Description

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This study will recruit 944 STEMI patients undergoing primary PCI with the symptom onset within 12 hours in 36 hospitals in Hubei Province, China. The patients will be 1:1 randomly assigned to the intervention group (IG) and control group (CG). Patients in IG will be intravenously administrated with sodium heparin (100U/Kg) at first medical contact, while patients in CG will be administrated with sodium heparin (100U/Kg) through catheter sheath in the CathLab.

Inclusion Criteria:

STEMI patient; Symptom onset in 12 hours; Intended to perform PPCI. Exclusion Criteria:Active bleeding; Life expectancy less than 1 year; History of heparin-induced thrombocytopenia; Mechanical complication of MI (VSR, acute MR); History of CABG; On Coagulation drugs; CPR before randomization; Pregnant or lactating woman;Refused to sign the Informed Consent Form.

Conditions

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STEMI Primary PCI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Administration of Heparin in ER

Administration of Heparin (100U/Kg body weight) with loading dose of DAPT (Aspirin 300mg and Ticagrelor 180mg) at first medical contact for STEMI patients intended to perform PPCI.

Group Type EXPERIMENTAL

Heparin Sodium Injection

Intervention Type DRUG

Heparin Sodium Injection (100U/Kg body weight)

Administration of Heparin in Cathlab

Administration of Heparin (100U/Kg body weight) in Cathlab after insertion of artery sheath catheter.

Group Type ACTIVE_COMPARATOR

Heparin Sodium Injection

Intervention Type DRUG

Heparin Sodium Injection (100U/Kg body weight)

Interventions

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Heparin Sodium Injection

Heparin Sodium Injection (100U/Kg body weight)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* STEMI patient; Symptom onset in 12 hours; Intended to perform PPCI

Exclusion Criteria

* Active bleeding; Life expectancy less than 1 year; History of heparin-induced thrombocytopenia; Mechanical complication of MI (VSR, acute MR); History of CABG; On Coagulation drugs; CPR before randomization; Pregnant or lactating woman.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No