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Cocktail Injection Improves Outcomes of FFR Guided PCI

NCT ID: NCT02592720

Last Updated: 2015-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-10-31

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.

Conditions

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Acute Coronary Syndromes

Keywords

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Acute Coronary Syndromes Fractional Flow Reserve Percutaneous Coronary Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

cocktail

Intervention Type DRUG

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).

FFR

Intervention Type DEVICE

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

QCA guided group

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

Group Type PLACEBO_COMPARATOR

QCA guided group

Intervention Type DEVICE

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

Interventions

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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).

Intervention Type DRUG

FFR

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

Intervention Type DEVICE

QCA guided group

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

Intervention Type DEVICE

Other Intervention Names

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cocktail (tirofiban, bivalirudin, tenecteplase) pressure wire (St. Jude Medical, Inc.)

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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sunddong

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dongdong Sun, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Air Force Military Medical University, China

Locations

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Xijing hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wanrong Man, MD

Role: CONTACT

Phone: 86 29 84775183

Email: [email protected]

Dongdong Sun, MD,Phd

Role: CONTACT

Phone: 86 29 84775183

Email: [email protected]

Facility Contacts

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Dongdong Sun, M.D.,Ph.D

Role: primary

Other Identifiers

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Cocktail II-FFR ACS

Identifier Type: -

Identifier Source: org_study_id