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CocktailII: Cocktail Injection Improves Outcomes of FFR Guided PCI

Sponsor
Xijing Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02592720
Collaborator
(none)
500
Enrollment
1
Location
2
Arms
24
Duration (Months)
20.8
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Oct 1, 2015
Anticipated Primary Completion Date :
Oct 1, 2017
Anticipated Study Completion Date :
Oct 1, 2017

Arms and Interventions

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).

    Outcome Measures

    Primary Outcome Measures

    1. Major adverse cardiac events [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 [1 year]

      left ventricular ejection fraction evaluated by ultrasound and MRI

    2. Seattle Angina Questionnaire scores [1 year]

      Seattle Angina Questionnaire scores

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

      Canadian Cardiovascular Society (CCS) Functional Angina classification

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

      6-minute walk distance (6MWD)

    5. stroke [1 year]

      number of participants with stroke

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xijing hospital Xi'an Shaanxi China 710032

    Sponsors and Collaborators

    • Xijing Hospital

    Investigators

    • Principal Investigator: Dongdong Sun, M.D.,Ph.D., Air Force Military Medical University, China

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    sunddong, Principal Investigator, Xijing Hospital
    ClinicalTrials.gov Identifier:
    NCT02592720
    Other Study ID Numbers:
    • Cocktail II-FFR ACS
    First Posted:
    Oct 30, 2015
    Last Update Posted:
    Oct 30, 2015
    Last Verified:
    Oct 1, 2015
    Keywords provided by sunddong, Principal Investigator, Xijing Hospital
    Acute Coronary Syndromes
    Fractional Flow Reserve
    Percutaneous Coronary Intervention
    Additional relevant MeSH terms:
    Acute Coronary Syndrome
    Tenecteplase
    Tirofiban
    Bivalirudin

    Study Results

    No Results Posted as of Oct 30, 2015