Cocktail Injection Improves Outcomes of FFR Guided PCI (CocktailII)

Air Force Military Medical University of People's Liberation Army

Status and phase: Unknown; Phase 4

Conditions: Acute Coronary Syndromes

Treatments: Drug: cocktail; Device: QCA guided group; Device: FFR

Study type: Interventional

Funder types: Other

Identifiers

NCT02592720

Cocktail II-FFR ACS

Details and patient eligibility

About

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).

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups, including a placebo group

Cocktail plus FFR guided group

Experimental group

Description:

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).

Treatment:

Device: FFR

Drug: cocktail

QCA guided group

Placebo Comparator group

Description:

Percutaneous Coronary Intervention (PCI) strategy is decided by QCA value in patients with acute coronary syndrome (ACS).

Treatment:

Device: QCA guided group