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Cocktail Injection Improves Outcomes of FFR Guided PCI (CocktailII)

Primary Purpose

Acute Coronary Syndromes

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
cocktail
FFR
QCA guided group
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndromes focused on measuring Acute Coronary Syndromes, Fractional Flow Reserve, Percutaneous Coronary Intervention

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Xijing hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cocktail plus FFR guided group

QCA guided group

Arm 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).

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 27, 2015
Last Updated
October 29, 2015
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02592720
Brief Title
Cocktail Injection Improves Outcomes of FFR Guided PCI
Acronym
CocktailII
Official Title
Intracoronary Cocktail Injection Improves Outcomes of Fractional Flow Reserve Guided Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrom (ACS)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndromes
Keywords
Acute Coronary Syndromes, Fractional Flow Reserve, Percutaneous Coronary Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cocktail plus FFR guided group
Arm Type
Experimental
Arm 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).
Arm Title
QCA guided group
Arm Type
Placebo Comparator
Arm Description
Percutaneous Coronary Intervention (PCI) strategy is decided by QCA value in patients with acute coronary syndrome (ACS).
Intervention Type
Drug
Intervention Name(s)
cocktail
Other Intervention Name(s)
cocktail (tirofiban, bivalirudin, tenecteplase)
Intervention 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).
Intervention Type
Device
Intervention Name(s)
FFR
Other Intervention Name(s)
pressure wire (St. Jude Medical, Inc.)
Intervention Description
Percutaneous Coronary Intervention (PCI) strategy is decided by FFR value in patients with acute coronary syndrome (ACS).
Intervention Type
Device
Intervention Name(s)
QCA guided group
Intervention Description
Percutaneous Coronary Intervention (PCI) strategy is decided by QCA value in patients with acute coronary syndrome (ACS).
Primary Outcome Measure Information:
Title
Major adverse cardiac events
Description
number of participants with death, myocardial infarction or class IV heart failure and target vessel revascularization revascularization
Time Frame
1 year
Secondary Outcome Measure Information:
Title
left ventricular function
Description
left ventricular ejection fraction evaluated by ultrasound and MRI
Time Frame
1 year
Title
Seattle Angina Questionnaire scores
Description
Seattle Angina Questionnaire scores
Time Frame
1 year
Title
Canadian Cardiovascular Society (CCS) Functional Angina classification
Description
Canadian Cardiovascular Society (CCS) Functional Angina classification
Time Frame
1 year
Title
6-minute walk distance (6MWD)
Description
6-minute walk distance (6MWD)
Time Frame
1 year
Title
stroke
Description
number of participants with stroke
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wanrong Man, MD
Phone
86 29 84775183
Email
manwanrong@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dongdong Sun, MD,Phd
Phone
86 29 84775183
Email
wintersun3@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dongdong Sun, M.D.,Ph.D.
Organizational Affiliation
Air Force Military Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xijing hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongdong Sun, M.D.,Ph.D
Phone
86 18691569930
Email
wintersun3@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Cocktail Injection Improves Outcomes of FFR Guided PCI

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