NCT05336669

Brief Summary

The activated clotting time (ACT), global thrombosis test (GTT-3), platelet inhibition P2Y12 (VerifyNow) test and serum coagulation factors will be measured in patients undergoing coronary angiography (CA) and percutaneous coronary intervention (PCI).

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
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2022

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

September 24, 2021

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

April 30, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

April 20, 2022

Status Verified

September 1, 2021

Enrollment Period

4 months

First QC Date

September 24, 2021

Last Update Submit

April 13, 2022

Conditions

Keywords

coronary angiographyactivated clotting timeplatelet inhibition

Outcome Measures

Primary Outcomes (3)

  • ACT change

    Activated Clotting Time

    Baseline ACT , 10 minutes ACT, 2 hours ACT, 6 hours ACT, 30 days ACT

  • GTT-3 change

    Global Thrombosis Test

    Baseline GTT-3, 10 minutes GTT-3, 2 hours GTT-3, 6 hours GTT-3, 30 days ACT

  • VerifyNow change

    Platelet inhibition P2Y12 test

    Baseline VerifyNow, 10 minutes VerifyNow, 2 hours VerifyNow, 6 hours VerifyNow, 30 days ACT

Study Arms (2)

Non-smoking

Non-smoking patients undergoing coronary angiography or percutaneous coronary intervention

Smoking

Smoking patients undergoing coronary angiography or percutaneous coronary intervention

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

40 patients, 20 smoking at least 10 cigarettes a day, 20 patients non-smoking (\<1 cigarette in last 30 days)

You may qualify if:

  • patients scheduled do CA \>18 years old

You may not qualify if:

  • pregnancy
  • previous treatment with P2Y12 inhibitors, novel oral anticoagulants (NOAC) or warfarin acenocoumarol in last 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ramotowski B, Lewandowski P, Slomski T, Maciejewski P, Budaj A. Platelet reactivity and activated clotting time predict hemorrhagic site complications in patients with chronic coronary syndromes undergoing percutaneous coronary interventions. Coron Artery Dis. 2024 Jun 1;35(4):292-298. doi: 10.1097/MCA.0000000000001336. Epub 2024 Jan 22.

Biospecimen

Retention: SAMPLES WITH DNA

2ml sample of full blood from each patient at baseline 4ml sample of plasma from each patient at each timepoint

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Bogumił Ramotowski

    Centre of Postgraduate Medical Education

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bogumił Ramotowski, MD, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

September 24, 2021

First Posted

April 20, 2022

Study Start

April 30, 2022

Primary Completion

August 31, 2022

Study Completion

August 31, 2023

Last Updated

April 20, 2022

Record last verified: 2021-09