NCT04047199

Brief Summary

To assess the predictive value of two scoring systems, namely HAS-BLED and CHA2DS2-VASc scores, to be linked with bleeding events and recurrence of chest pain and other measures of clinical outcome of percutaneous coronary intervention. The investigators aim to provide evidence for local guidelines of optimum options suited to our population

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
173

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

August 3, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

August 26, 2019

Status Verified

August 1, 2019

Enrollment Period

6 months

First QC Date

August 3, 2019

Last Update Submit

August 21, 2019

Conditions

Keywords

Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (2)

  • Rate of bleeding events

    number of bleeding events (epistaxis, bleeding gums, haematuria, GI bleeding, brain bleeding)

    6 months after PCI

  • Rate of ischaemic events

    number of ischaemic events (ACS, TIA, stroke, acute limb ischaemia, GI, ischaemia)

    6 months after PCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients who are scheduled for elective PCI (Percutaneous Coronary Intervention) and also those who undergo urgent primary PCI

You may qualify if:

  • all patients undergoing PCI

You may not qualify if:

  • Those who had undergone unexpected immediate CABG

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Koene RJ, Win S, Naksuk N, Adatya SN, Rosenbaum AN, John R, Eckman PM. HAS-BLED and CHA(2)DS(2)-VASc scores as predictors of bleeding and thrombotic risk after continuous-flow ventricular assist device implantation. J Card Fail. 2014 Nov;20(11):800-7. doi: 10.1016/j.cardfail.2014.08.010. Epub 2014 Aug 23.

    PMID: 25152496BACKGROUND

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 3, 2019

First Posted

August 6, 2019

Study Start

December 1, 2019

Primary Completion

June 1, 2020

Study Completion

July 1, 2020

Last Updated

August 26, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share