NCT03664388

Brief Summary

CardoCHUVI registry was aim to study ischemic and bleeding complication after an acute coronary syndrome (ACS), both in-hospital and follow-up events.

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
8,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Longer than P75 for all trials

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

February 1, 2016

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2018

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

September 10, 2018

Status Verified

September 1, 2018

Enrollment Period

2.6 years

First QC Date

September 6, 2018

Last Update Submit

September 7, 2018

Conditions

Acute Coronary Syndrome

Keywords

Acute Coronary Syndrome; Bleeding; Dual antiplatelet therapy

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    Death for any cause

    Through study completion, an average of 3 years

Secondary Outcomes (6)

  • Reinfarction

    Through study completion, an average of 3 years

  • Bleeding

    Through study completion, an average of 3 years

  • Ischemic stroke

    Through study completion, an average of 3 years

  • Cancer

    Through study completion, an average of 3 years

  • Heart Failure

    Through study completion, an average of 3 years

  • +1 more secondary outcomes

Interventions

Dual antiplatelet therapy with ticagrelor/prasuglreDRUG

Compare bleeding and ischemic events according to the type and duration of dual antiplatelet therapy

Also known as: Dual antiplatelet therapy with clopidogrel

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients admitted by acute coronary syndrome in the University Hospital Alvaro Cunqueiro of Vigo between January 2010 to January 2018

You may qualify if:

  • Any patient admitted to University Hospital Alvaro Cunqueiro of Vigo for acute coronary syndrome.

You may not qualify if:

  • Secondary acute coronary syndromes during a hospital admission for another cause (i.e. acute myocardial infarction in the context of a sepsis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Hospital Álvaro Cunqueiro

Vigo, Pontevedra, 36312, Spain

RECRUITING

MeSH Terms

Conditions

Acute Coronary SyndromeHemorrhage

Interventions

TicagrelorClopidogrel

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesTiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Emad Abu-Assi, MD, PhD

    University Hospital Álvaro Cunqueiro, Vigo, Spain

    STUDY CHAIR

  • Sergio Raposeiras-Roubín, MD, PhD

    University Hospital Álvaro Cunqueiro, Vigo, Spain

    PRINCIPAL INVESTIGATOR

  • Andres Iñiguez-Romo, MD, PhD

    University Hospital Álvaro Cunqueiro, Vigo, Spain

    STUDY DIRECTOR

Central Study Contacts

Sergio Raposeiras Roubín, MD, PhD

CONTACT

0034 620170387raposeiras26@hotmail.com

Emad Abu Assi, MD, PhD

CONTACT

eabuassi@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2018

First Posted

September 10, 2018

Study Start

February 1, 2016

Primary Completion

September 6, 2018

Study Completion

February 1, 2020

Last Updated

September 10, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Registry of all consecutive patients admitted by acute coronary syndrome (ACS) to an university hospital in order to analyze bleeding and ischemic complications according to the type and duration of dual antiplatelet therapy

Locations

ES(1)