Cocktail Injection Improves Outcomes of FFR Guided PCI (CocktailII)

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

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).

Study Overview

• Status: Unknown
• Conditions: Acute Coronary Syndromes
• Intervention / Treatment: Drug: cocktail; Device: FFR; Device: QCA guided group

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 Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xijing Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): October 1, 2017

Study Registration Dates

• First Submitted: October 27, 2015
• First Submitted That Met QC Criteria: October 29, 2015
• First Posted (Estimate): October 30, 2015

Study Record Updates

• Last Update Posted (Estimate): October 30, 2015
• Last Update Submitted That Met QC Criteria: October 29, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Fractional Flow Reserve; Acute Coronary Syndromes
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Bivalirudin; Tirofiban; Tenecteplase
• Other Study ID Numbers: Cocktail II-FFR ACS