Intracoronary Cocktail Injection Combined With Thrombus Aspiration in STEMI Patients Treated With Primary Angioplasty

Air Force Military Medical University of People's Liberation Army

Status and phase: Unknown; Phase 4

Conditions: ST-elevation Myocardial Infarction

Treatments: Drug: cocktail; Device: thrombus aspiration

Study type: Interventional

Funder types: Other

Identifiers

NCT02592694

Cocktail I

Details and patient eligibility

About

This is a randomized, double blind, placebo controlled study of intracoronary cocktail injection combined with thrombus aspiration versus thrombus aspiration alone in ST-elevation myocardial infarction patients treated with primary angioplasty.

Full description

This is a randomized, double blind, placebo controlled study of intracoronary cocktail injection combined with thrombus aspiration versus thrombus aspiration alone in ST-elevation myocardial infarction patients treated with primary angioplasty. Patients with STEMI will be randomized into the cocktail group or the control group. Patients in the cocktail group will receive cocktail injection combined with thrombus aspiration. Patients in the control group will receive thrombus aspiration alone. The primary outcome of the cocktail I study is the composite of death, myocardial infarction or class IV heart failure within 1 year. The secondary outcome of the cocktail I study include slow reflow/no reflow during PCI, left ventricular function, quality of life, stroke or life-threatening bleeding within 1 year.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-80 years of age adult patients with STEMI Referred for primary PCI within 5d of symptom onset

Exclusion criteria

• Patients who had undergone previous coronary artery bypass surgery or PCI or had received fibrinolytic therapy History of stroke Active bleeding Severe hepatic or renal dysfunction Cardiogenic shock Contraindications for primary PCI or DAPT

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,000 participants in 2 patient groups

Cocktail with thrombus aspiration

Experimental group

Description:

Intracoronary cocktail (tirofiban, bivalirudin, tenecteplase) injection combined with thrombus aspiration

Treatment:

Device: thrombus aspiration

Drug: cocktail

Thrombus aspiration

Active Comparator group

Description:

Thrombus aspiration alone

Treatment:

Device: thrombus aspiration