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Cocktail Injection Improves Outcomes of FFR Guided PCI (CocktailII)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02592720
Recruitment Status : Unknown
Verified October 2015 by sunddong, Xijing Hospital.
Recruitment status was:  Recruiting
First Posted : October 30, 2015
Last Update Posted : October 30, 2015
Sponsor:
Information provided by (Responsible Party):
sunddong, 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).

Condition or disease Intervention/treatment Phase
Acute Coronary Syndromes Drug: cocktail Device: FFR Device: QCA guided group Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intracoronary Cocktail Injection Improves Outcomes of Fractional Flow Reserve Guided Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrom (ACS)
Study Start Date : October 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

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 Name: cocktail (tirofiban, bivalirudin, tenecteplase)

Device: FFR
Percutaneous Coronary Intervention (PCI) strategy is decided by FFR value in patients with acute coronary syndrome (ACS).
Other Name: 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).




Primary Outcome Measures :
  1. Major adverse cardiac events [ Time Frame: 1 year ]
    number of participants with death, myocardial infarction or class IV heart failure and target vessel revascularization revascularization


Secondary Outcome Measures :
  1. left ventricular function [ Time Frame: 1 year ]
    left ventricular ejection fraction evaluated by ultrasound and MRI

  2. Seattle Angina Questionnaire scores [ Time Frame: 1 year ]
    Seattle Angina Questionnaire scores

  3. Canadian Cardiovascular Society (CCS) Functional Angina classification [ Time Frame: 1 year ]
    Canadian Cardiovascular Society (CCS) Functional Angina classification

  4. 6-minute walk distance (6MWD) [ Time Frame: 1 year ]
    6-minute walk distance (6MWD)

  5. stroke [ Time Frame: 1 year ]
    number of participants with stroke



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592720


Contacts
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Contact: Wanrong Man, MD 86 29 84775183 manwanrong@gmail.com
Contact: Dongdong Sun, MD,Phd 86 29 84775183 wintersun3@gmail.com

Locations
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China, Shaanxi
Xijing hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Dongdong Sun, M.D.,Ph.D    86 18691569930    wintersun3@gmail.com   
Sponsors and Collaborators
Xijing Hospital
Investigators
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Principal Investigator: Dongdong Sun, M.D.,Ph.D. Fourth Military Medical University

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Responsible Party: sunddong, Principal Investigator, Xijing Hospital
ClinicalTrials.gov Identifier: NCT02592720    
Other Study ID Numbers: Cocktail II-FFR ACS
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: October 30, 2015
Last Verified: October 2015
Keywords provided by sunddong, Xijing Hospital:
Acute Coronary Syndromes
Fractional Flow Reserve
Percutaneous Coronary Intervention
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Tenecteplase
Bivalirudin
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents