Coagulation Profile in Patients Undergoing Coronary Angiography and Percutaneous Coronary Intervention
GlobalACT
1 other identifier
observational
40
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2021
CompletedFirst Posted
Study publicly available on registry
April 20, 2022
CompletedStudy Start
First participant enrolled
April 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2023
CompletedApril 20, 2022
September 1, 2021
4 months
September 24, 2021
April 13, 2022
Conditions
Keywords
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
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.
PMID: 38241058DERIVED
Biospecimen
2ml sample of full blood from each patient at baseline 4ml sample of plasma from each patient at each timepoint
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bogumił Ramotowski
Centre of Postgraduate Medical Education
Central Study Contacts
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