Cocktail Injection Improves Outcomes of FFR Guided PCI

Phase 4

• Conditions: Acute Coronary Syndromes
• Interventions: Drug: cocktail; Device: QCA guided group; Device: FFR

• Registration Number: NCT02592720
• Lead Sponsor: Xijing Hospital

Brief 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).

Detailed 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.

Study Timeline

• Status Verified: 2015-10
• Study Start: 2015-10
• Study First Submitted: 2015-10-27
• Study First Submitted QC: 2015-10-29
• Last Update Submitted: 2015-10-29
• 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: 500

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cocktail plus FFR guided group	FFR	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).
Cocktail plus FFR guided group	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).
QCA guided group	QCA guided group	Percutaneous Coronary Intervention (PCI) strategy is decided by QCA value in patients with acute coronary syndrome (ACS).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
stroke	1 year	number of participants with stroke
Seattle Angina Questionnaire scores	1 year	Seattle Angina Questionnaire scores
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
6-minute walk distance (6MWD)	1 year	6-minute walk distance (6MWD)

Trial Locations

Locations (1)

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