Cocktail Injection Improves Outcomes of FFR Guided PCI

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Coronary Syndromes

Intervention / Treatment
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* Drug: cocktail
* Device: FFR
* Device: QCA guided group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cocktail plus FFR guided group<br>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). | Drug: cocktail<br>* 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).<br>* Other names: cocktail (tirofiban, bivalirudin, tenecteplase);Device: FFR<br>* Percutaneous Coronary Intervention (PCI) strategy is decided by FFR value in patients with acute coronary syndrome (ACS).<br>* Other names: pressure wire (St. Jude Medical, Inc.);|
| Placebo Comparator: QCA guided group<br>Percutaneous Coronary Intervention (PCI) strategy is decided by QCA value in patients with acute coronary syndrome (ACS). | Device: QCA guided group<br>* Percutaneous Coronary Intervention (PCI) strategy is decided by QCA value in patients with acute coronary syndrome (ACS).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events | number of participants with death, myocardial infarction or class IV heart failure and target vessel revascularization revascularization | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| left ventricular function | left ventricular ejection fraction evaluated by ultrasound and MRI | 1 year | 
| Seattle Angina Questionnaire scores | Seattle Angina Questionnaire scores | 1 year | 
| Canadian Cardiovascular Society (CCS) Functional Angina classification | Canadian Cardiovascular Society (CCS) Functional Angina classification | 1 year | 
| 6-minute walk distance (6MWD) | 6-minute walk distance (6MWD) | 1 year | 
| stroke | number of participants with stroke | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Coronary Syndromes, Fractional Flow Reserve, Percutaneous Coronary Intervention