NCT02592720

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 30, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

October 30, 2015

Status Verified

October 1, 2015

Enrollment Period

2 years

First QC Date

October 27, 2015

Last Update Submit

October 29, 2015

Conditions

Acute Coronary Syndromes

Keywords

Acute Coronary SyndromesFractional Flow ReservePercutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiac events

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

    1 year

Secondary Outcomes (5)

  • left ventricular function

    1 year

  • Seattle Angina Questionnaire scores

    1 year

  • Canadian Cardiovascular Society (CCS) Functional Angina classification

    1 year

  • 6-minute walk distance (6MWD)

    1 year

  • stroke

    1 year

Study Arms (2)

Cocktail plus FFR guided group

EXPERIMENTAL

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: cocktailDevice: FFR

QCA guided group

PLACEBO COMPARATOR

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

Device: QCA guided group

Interventions

cocktailDRUG

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).

Also known as: cocktail (tirofiban, bivalirudin, tenecteplase)
Cocktail plus FFR guided group
FFRDEVICE

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

Also known as: pressure wire (St. Jude Medical, Inc.)
Cocktail plus FFR guided group
QCA guided groupDEVICE

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

QCA guided group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with a clinical diagnosis of recent ACS within 5 days

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

TirofibanbivalirudinTenecteplase

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

TyrosineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsTissue Plasminogen ActivatorSerine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteins

Study Officials

  • Dongdong Sun, M.D.,Ph.D.

    Air Force Military Medical University, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wanrong Man, MD

CONTACT

86 29 84775183manwanrong@gmail.com

Dongdong Sun, MD,Phd

CONTACT

86 29 84775183wintersun3@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 27, 2015

First Posted

October 30, 2015

Study Start

October 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

October 30, 2015

Record last verified: 2015-10

Locations

CN(1)