NCT02592694

Brief Summary

This is a randomized, double blind, placebo controlled study of intracoronary cocktail injection combined with thrombus aspiration versus thrombus aspiration alone in ST-elevation myocardial infarction patients treated with primary angioplasty.

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
1,000

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
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2015

Completed
4 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 26, 2015

Last Update Submit

October 28, 2015

Conditions

ST-elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Death, Mayocardial infarction, NYHA Ⅳ heart failure

    number of participants with death, mayocardial infarction or NYHA Ⅳ heart failure

    1 year

Secondary Outcomes (6)

  • Slow reflow/no reflow

    intraoperative

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Cocktail with thrombus aspiration

EXPERIMENTAL

Intracoronary cocktail (tirofiban, bivalirudin, tenecteplase) injection combined with thrombus aspiration

Drug: cocktailDevice: thrombus aspiration

Thrombus aspiration

ACTIVE COMPARATOR

Thrombus aspiration alone

Device: thrombus aspiration

Interventions

cocktailDRUG

Cocktail (tirofiban, bivalirudin, tenecteplase) will be given in addition to thrombus aspiration

Also known as: tirofiban, bivalirudin, tenecteplase
Cocktail with thrombus aspiration
thrombus aspirationDEVICE

manual thrombus aspiration

Also known as: manual thrombus aspiration
Cocktail with thrombus aspirationThrombus aspiration

Eligibility Criteria

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

You may qualify if:

  • years of age adult patients with STEMI Referred for primary PCI within 5d of symptom onset

You may not qualify if:

  • Patients who had undergone previous coronary artery bypass surgery or PCI or had received fibrinolytic therapy History of stroke Active bleeding Severe hepatic or renal dysfunction Cardiogenic shock Contraindications for primary PCI or DAPT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

TirofibanbivalirudinTenecteplase

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

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

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

CONTACT

86 29 84775183wintersun3@gmail.com

Study Design

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

Study Record Dates

First Submitted

October 26, 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)