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

ST-elevation Myocardial Infarction Clinical Trial

Official title:

Intracoronary Cocktail Injection Combined With Thrombus Aspiration in ST-elevation Myocardial Infarction Patients Treated With Primary Angioplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02592694
• Other study ID #: Cocktail I
• Status: Recruiting
• Phase: Phase 4
• First received: October 26, 2015
• Last updated: October 28, 2015
• Start date: October 2015
• Est. completion date: October 2017

Study information

• Verified date: October 2015
• Source: Xijing Hospital
• Contact: Dongdong Sun, M.D.,Ph.D.
• Phone: 86 29 84775183
• Email: wintersun3[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST-elevation Myocardial Infarction

Intervention

Drug:
• cocktail
Cocktail (tirofiban, bivalirudin, tenecteplase) will be given in addition to thrombus aspiration

Device:
• thrombus aspiration
manual thrombus aspiration

Locations

Country	Name	City	State
China	Xijing hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death, Mayocardial infarction, NYHA ? heart failure	number of participants with death, mayocardial infarction or NYHA ? heart failure	1 year	No
Secondary	Slow reflow/no reflow	number of participants with slow reflow/no reflow during PCI	intraoperative	Yes
Secondary	Left ventricular function	left ventricular ejection fraction evaluated by ultrasound and MRI	1 year	No
Secondary	Seattle Angina Questionnaire scores	Seattle Angina Questionnaire scores	1 year	No
Secondary	Canadian Cardiovascular Society (CCS) Functional Angina classification	Canadian Cardiovascular Society (CCS) Functional Angina classification	1 year	No
Secondary	6-minute walk distance (6MWD)	6-minute walk distance (6MWD)	1 year	No
Secondary	Stroke	number of participants with stroke	1 year	Yes