NCT05505591

Brief Summary

The study will investigate the prevalence of high bleeding risk (HBR) features and will compare the clinical outcomes of HBR and non-HBR patients among those undergoing percutaneous coronary intervention and receiving cangrelor infusion.

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
900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

June 6, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

5 months

First QC Date

August 9, 2022

Last Update Submit

August 11, 2022

Conditions

BleedingCoronary Artery DiseaseMyocardial Infarction

Keywords

Percutaneous coronary interventionCangrelorHigh bleeding riskCoronary artery diseaseAcute myocardial infarction

Outcome Measures

Primary Outcomes (1)

  • Rate of NACE

    A composite of cardiovascular death, myocardial infarction, stroke, definite or probable stent thrombosis and Bleeding Academic Research Consortium 2-5 bleeding

    48 hours

Secondary Outcomes (15)

  • Rate of MACE

    48 hours

  • Rate of cardiovascular death

    48 hours

  • Rate of myocardial infarction (periprocedural)

    48 hours

  • Rate of ischemic stroke

    48 hours

  • Rate of hemorrhagic stroke

    48 hours

  • +10 more secondary outcomes

Other Outcomes (5)

  • Rate of all-cause death

    48 hours

  • Rate of thrombolysis in myocardial infarction (TIMI) major bleeding

    48 hours

  • Rate of thrombolysis in myocardial infarction (TIMI) minor bleeding

    48 hours

  • +2 more other outcomes

Study Arms (2)

High bleeding risk

Patients treated with cangrelor who met the Academic Research Consortium (ARC) definition of high bleeding risk (HBR)

Drug: Cangrelor

Non-high bleeding risk

Patients treated with cangrelor who did not meet the Academic Research Consortium (ARC) definition of high bleeding risk (HBR)

Drug: Cangrelor

Interventions

CangrelorDRUG

Cangrelor administration during percutaneous coronary intervention for both chronic or acute coronary syndromes

High bleeding riskNon-high bleeding risk

Eligibility Criteria

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

Consecutive patients undergoing percutaneous coronary intervention with cangrelor infusion will be included.

You may qualify if:

  • Age ≥ 18 years
  • Cangrelor administration during percutaneous coronary intervention for both acute and chronic coronary syndromes

You may not qualify if:

  • \. Cangrelor administration as a bridge to surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Università degli Studi della Campania "Luigi Vanvitelli"

Caserta, 81100, Italy

RECRUITING

University of Genoa

Genova, 16132, Italy

RECRUITING

Related Publications (1)

  • Benenati S, Gragnano F, Scalamera R, De Sio V, Capolongo A, Cesaro A, Annibali G, Campagnuolo S, Silverio A, Bellino M, Centore M, Schettino M, Bertero E, Caretta G, Rezzaghi M, Veneziano F, De Nardo D, De Rosa G, De Luca L, Galasso G, Menozzi A, Musumeci G, Cirillo P, Calabro P, Porto I. ICARUS score for predicting peri-procedural bleeding in patients undergoing percutaneous coronary intervention with cangrelor. Int J Cardiol. 2024 Dec 15;417:132568. doi: 10.1016/j.ijcard.2024.132568. Epub 2024 Sep 14.

    PMID: 39284439DERIVED

MeSH Terms

Conditions

HemorrhageCoronary Artery DiseaseMyocardial Infarction

Interventions

cangrelor

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionIschemiaNecrosis

Central Study Contacts

Italo Porto, MD, PhD

CONTACT

+39 0105555830italo.porto@unige.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor of Cardiology

Study Record Dates

First Submitted

August 9, 2022

First Posted

August 18, 2022

Study Start

June 6, 2022

Primary Completion

October 31, 2022

Study Completion

October 31, 2022

Last Updated

August 18, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)