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

Phase 4

• Conditions: ST-elevation Myocardial Infarction
• Interventions: Drug: cocktail; Device: thrombus aspiration

• Registration Number: NCT02592694
• Lead Sponsor: Xijing Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2015-10
• Study Start: 2015-10
• Study First Submitted: 2015-10-26
• Study First Submitted QC: 2015-10-28
• Last Update Submitted: 2015-10-28
• Study First Posted: 2015-10-30
• Last Update Posted: 2015-10-30
• Primary Completion: 2017-10
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cocktail with thrombus aspiration	cocktail	Intracoronary cocktail (tirofiban, bivalirudin, tenecteplase) injection combined with thrombus aspiration
Cocktail with thrombus aspiration	thrombus aspiration	Intracoronary cocktail (tirofiban, bivalirudin, tenecteplase) injection combined with thrombus aspiration
Thrombus aspiration	thrombus aspiration	Thrombus aspiration alone

Primary Outcome Measures

Name	Time	Method
Death, Mayocardial infarction, NYHA Ⅳ heart failure	1 year	number of participants with death, mayocardial infarction or NYHA Ⅳ heart failure

Secondary Outcome Measures

Name	Time	Method
Left ventricular function	1 year	left ventricular ejection fraction evaluated by ultrasound and MRI
Canadian Cardiovascular Society (CCS) Functional Angina classification	1 year	Canadian Cardiovascular Society (CCS) Functional Angina classification
Seattle Angina Questionnaire scores	1 year	Seattle Angina Questionnaire scores
6-minute walk distance (6MWD)	1 year	6-minute walk distance (6MWD)
Stroke	1 year	number of participants with stroke
Slow reflow/no reflow	intraoperative	number of participants with slow reflow/no reflow during PCI

Trial Locations

Locations (1)

Xijing hospital; 🇨🇳 Xi'an, Shaanxi, China