Cocktail Injection Improves Outcomes of FFR Guided PCI

Acute Coronary Syndromes Clinical Trial

— CocktailII  

Official title:

Intracoronary Cocktail Injection Improves Outcomes of Fractional Flow Reserve Guided Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrom (ACS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02592720
• Other study ID #: Cocktail II-FFR ACS
• Status: Recruiting
• Phase: Phase 4
• First received: October 27, 2015
• Last updated: October 29, 2015
• Start date: October 2015
• Est. completion date: October 2017

Study information

• Verified date: October 2015
• Source: Xijing Hospital
• Contact: Wanrong Man, MD
• Phone: 86 29 84775183
• Email: manwanrong[@]gmail.com
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial Summary

This is a randomized, single blind, controlled study of intracoronary cocktail injection before fractional flow reserve (FFR) measurement when guiding percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS).

Description:

This is a randomized, single blind, controlled study of intracoronary cocktail injection before fractional flow reserve (FFR) measurement when guiding percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS). Patients with ACS will be randomized into the cocktail plus FFR guided group or the QCA guided group. The primary outcome of the cocktail II study is the composite of death, myocardial infarction, class IV heart failure and target vessel revascularization within 1 year. The secondary outcome of the cocktail II study include left ventricular function, quality of life, stroke or life-threatening bleeding within 1 year.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• 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:

• patients with a clinical diagnosis of recent ACS within 5 days

Exclusion Criteria:

• haemodynamic instability

• intolerance to anti-platelet drugs

• ineligible for coronary revascularization

• a treatment plan for non-coronary heart surgery (e.g. valve surgery)

• a history of prior PCI or CABG

• angiographic evidence of severe (e.g. diffuse calcification) or mild (<30% severity) coronary disease

• a life expectancy less than 1 year

• adenosine allergy

Study Design

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes

Intervention

Drug:
• cocktail
Intracoronary cocktail injection before fractional flow reserve (FFR) measurement. Percutaneous Coronary Intervention (PCI) strategy is decided by FFR value in patients with acute coronary syndrome (ACS).

Device:
• FFR
Percutaneous Coronary Intervention (PCI) strategy is decided by FFR value in patients with acute coronary syndrome (ACS).
• QCA guided group
Percutaneous Coronary Intervention (PCI) strategy is decided by QCA value in patients with acute coronary syndrome (ACS).

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	Major adverse cardiac events	number of participants with death, myocardial infarction or class IV heart failure and target vessel revascularization revascularization	1 year	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