Chronic Coronary InsufficiencyGlobalACTNCT05336669
Coagulation Profile in Patients Undergoing Coronary Angiography and Percutaneous Coronary Intervention
An observational study of Chronic Coronary Insufficiency and Smoking, run by Centre of Postgraduate Medical Education.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Coronary Insufficiency, Smoking
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2022to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 40 patients, 20 smoking at least 10 cigarettes a day, 20 patients non-smoking (<1 cigarette in last 30 days)
Who may be able to join
- patients scheduled do CA >18 years old
Who cannot join
- pregnancy
- previous treatment with P2Y12 inhibitors, novel oral anticoagulants (NOAC) or warfarin acenocoumarol in last 24 hours
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Coagulation Profile in Patients Undergoing Coronary Intervention Measured With Activated Clotting Time, Global Thrombosis Test and Platelet Inhibition VerifyNow P2Y12 Test
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).
Read the detailed description
The activated clotting time (ACT), global thrombosis test (GTT-3) and platelet inhibition P2Y12 (VerifyNow) test and serum coagulation factors will be measured in patients undergoing coronary angiography (CA) and percutaneous coronary intervention (PCI) - 20 smoking and 20 non-smoking.The measurements will take place: before coronary angiography (CA), 10 minutes after unfractionated heparin (HNF), 2h after CA, 6h after CA, 30 days after CA
- Conditions
- Chronic Coronary Insufficiency, Smoking
- Keywords
- coronary angiography, activated clotting time, platelet inhibition
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-smoking | Non-smoking patients undergoing coronary angiography or percutaneous coronary intervention | |
| Smoking | Smoking patients undergoing coronary angiography or percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACT change
Activated Clotting Time
Measured: Baseline ACT , 10 minutes ACT, 2 hours ACT, 6 hours ACT, 30 days ACT
GTT-3 change
Global Thrombosis Test
Measured: Baseline GTT-3, 10 minutes GTT-3, 2 hours GTT-3, 6 hours GTT-3, 30 days ACT
VerifyNow change
Platelet inhibition P2Y12 test
Measured: Baseline VerifyNow, 10 minutes VerifyNow, 2 hours VerifyNow, 6 hours VerifyNow, 30 days ACT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start30 Apr 2022 (estimated)
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Coronary InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre of Postgraduate Medical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bogumił Ramotowski, Principal investigator, Centre of Postgraduate Medical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336669
- Sponsor's protocol ID
- 69/VII/Budaj/2021
- Acronym
- GlobalACT
- Status last verified
- Sep 2021
- First submitted
- 24 Sep 2021
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38241058
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coagulation Profile in Patients Undergoing Coronary Intervention Measured With Activated Clotting Time, Global Thrombosis Test and Platelet Inhibition VerifyNow P2Y12 Test
- ClinicalTrials.gov ID
- NCT05336669
- Acronym / sponsor ID
- GlobalACT / 69/VII/Budaj/2021
- Conditions
- Chronic Coronary Insufficiency, Smoking
- Keywords
- coronary angiography, activated clotting time, platelet inhibition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre of Postgraduate Medical EducationUniversity, hospital or other
- Study start
- 30 Apr 2022 (estimated)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The activated clotting time (ACT), global thrombosis test (GTT-3) and platelet inhibition P2Y12 (VerifyNow) test and serum coagulation factors will be measured in patients undergoing coronary angiography (CA) and percutaneous coronary intervention (PCI) - 20 smoking and 20 non-smoking.The measurements will take place: before coronary angiography (CA), 10 minutes after unfractionated heparin (HNF), 2h after CA, 6h after CA, 30 days after CA
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-smoking | – | –Non-smoking patients undergoing coronary angiography or percutaneous coronary intervention |
| Smoking | – | –Smoking patients undergoing coronary angiography or percutaneous coronary intervention |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 40 patients, 20 smoking at least 10 cigarettes a day, 20 patients non-smoking (<1 cigarette in last 30 days)
Key inclusion criteria (1 listed)
- patients scheduled do CA >18 years old
Key exclusion criteria (2 listed)
- pregnancy
- previous treatment with P2Y12 inhibitors, novel oral anticoagulants (NOAC) or warfarin acenocoumarol in last 24 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ACT change
Time frame: Baseline ACT , 10 minutes ACT, 2 hours ACT, 6 hours ACT, 30 days ACT
Activated Clotting Time
GTT-3 change
Time frame: Baseline GTT-3, 10 minutes GTT-3, 2 hours GTT-3, 6 hours GTT-3, 30 days ACT
Global Thrombosis Test
VerifyNow change
Time frame: Baseline VerifyNow, 10 minutes VerifyNow, 2 hours VerifyNow, 6 hours VerifyNow, 30 days ACT
Platelet inhibition P2Y12 test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Derived from this study: PubMed 38241058Ramotowski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bogumił Ramotowski principal investigator
Centre of Postgraduate Medical Education
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Coronary Insufficiency and Smoking, run by Centre of Postgraduate Medical Education.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bogumił Ramotowski, MD, PhD (+48604355784, bram@onet.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACT change (time frame: Baseline ACT , 10 minutes ACT, 2 hours ACT, 6 hours ACT, 30 days ACT). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05336669, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.