Coronary AngiographyPhase 4NCT02570243
High (100IU/Kg) Versus Standard (50IU/Kg) Heparin Dose for Prevention of Forearm Artery Occlusion
A Phase 4 study testing High dose of Unfractionated Heparin and Standard dose of Unfractionated heparin in people with Coronary Angiography, run by University of Patras at 1 site in Greece.
Trial summary
This is a prospective, multi-center, superiority study of parallel design. Patients are enrolled if they are older than 18 years old, are scheduled for 5 or 6 Fr diagnostic coronary angiography and the interventional cardiologist is willing to proceed with radial access. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Angiography
- What is being tested?
- High dose of Unfractionated Heparin and Standard dose of Unfractionated heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 1 siteGreece
- Study dates
- Feb 2015to Sep 2017
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18 years old
- Scheduled for 5 or 6 Fr diagnostic coronary angiography
- The interventional cardiologist is willing to proceed with radial access
- Written informed consent
Who cannot join
- Before randomization
- chronic hemodialysis
- oral anticoagulation
- hemodynamic instability
- severe dermo-myoskeletal forearm deformities
- history of CABG and bilateral use of either the internal mammary or radial artery
Show all 10Show fewer
- history of CABG and ipsilateral use of both the internal mammary and radial artery
- admission for elective PCI After randomization
- crossover to another arterial access site is required
- ad hoc PCI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High (100IU/Kg) Versus Standard (50IU/Kg) Heparin Dose for Prevention of Forearm Artery Occlusion Forearm Artery Occlusion
This is a prospective, multi-center, superiority study of parallel design. Patients are enrolled if they are older than 18 years old, are scheduled for 5 or 6 Fr diagnostic coronary angiography and the interventional cardiologist is willing to proceed with radial access. Patients are randomized before diagnostic catheterization to receive intravenously either 100IU/Kg or 50 IU/Kg of unfractionated heparin (UFH) in a 1:1 ratio. Patients are discharged usually within 4 to 6 hours after coronary angiography.
Radial artery in each patient is evaluated either in-hospital or during a subsequent visit by one physician who is blinded to the actual antithrombotic treatment given. Radial artery is considered occluded if it exhibits ultrasonographically no antegrade flow signal both at baseline and after reevaluation on a second occasion, within 30 days after the index procedure. Initially patent arteries will not be reexamined and are thought to remain permanently patent. The investigators also monitor major bleeding (defined as ≥ 5g/dL decrease in hemoglobin or ≥15% decrease in hematocrit or any life-threatening bleeding (confirmed by MRI or computed tomography) and large local hematomas of the forearm (defined as those extending beyond the forearm).
- Conditions
- Coronary Angiography
- Being tested
- High dose of Unfractionated Heparin, Standard dose of Unfractionated heparin
- Keywords
- heparin, radial artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dose of Unfractionated HeparinDrug
Unfractionated Heparin 100IU/Kg
Standard dose of Unfractionated heparinDrug
Unfractionated heparin 50IU/Kg
| Study group | Role | What they receive |
|---|---|---|
| Standard dose of Heparin | Active comparator | 50IU/Kg heparin intravenously Receives: Drug: Standard dose of Unfractionated heparin |
| High dose of Heparin | Experimental | 100IU/Kg heparin intravenously Receives: Drug: High dose of Unfractionated Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radial artery occlusion
Radial artery occlusion as assessed by Doppler Ultrasound
Measured: 30 days
Secondary outcomes (2)
Large local hematomas of the forearm
large local hematomas of the forearm (defined as those extending beyond the forearm)
Measured: 30 days
Major bleeding
≥ 5g/dL decrease in hemoglobin or ≥15% decrease in hematocrit or any life-threatening bleeding (confirmed by MRI or computed tomography)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startFeb 2015
- Primary completionSep 2017
- Study completionSep 2017
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 Coronary AngiographyStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitrios Alexopoulos, University of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570243
- Sponsor's protocol ID
- PATRASCARDIOLOGY 20
- Status last verified
- Sep 2017
- First submitted
- 5 Oct 2015
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hahalis GN, Leopoulou M, Tsigkas G, Xanthopoulou I, Patsilinakos S, Patsourakos NG, Ziakas A, Kafkas N, Koutouzis M, Tsiafoutis I, Athanasiadis I, Koniari I, Almpanis G, Anastasopoulou M, Despotopoulos S, Kounis N, Dapergola A, Aznaouridis K, Davlouros P. Multicenter Randomized Evaluation of High Versus Standard Heparin Dose on Incident Radial Arterial Occlusion After Transradial Coronary Angiography: The SPIRIT OF ARTEMIS Study. JACC Cardiovasc Interv. 2018 Nov 26;11(22):2241-2250. doi: 10.1016/j.jcin.2018.08.009. Epub 2018 Nov 1.
PubMed 30391389
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High (100IU/Kg) Versus Standard (50IU/Kg) Heparin Dose for Prevention of Forearm Artery Occlusion Forearm Artery Occlusion
- ClinicalTrials.gov ID
- NCT02570243
- Acronym / sponsor ID
- PATRASCARDIOLOGY 20
- Conditions
- Coronary Angiography
- Keywords
- heparin, radial artery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 7 Oct 2015 (estimated)
- 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.
This is a prospective, multi-center, superiority study of parallel design. Patients are enrolled if they are older than 18 years old, are scheduled for 5 or 6 Fr diagnostic coronary angiography and the interventional cardiologist is willing to proceed with radial access. Patients are randomized before diagnostic catheterization to receive intravenously either 100IU/Kg or 50 IU/Kg of unfractionated heparin (UFH) in a 1:1 ratio. Patients are discharged usually within 4 to 6 hours after coronary angiography.
Radial artery in each patient is evaluated either in-hospital or during a subsequent visit by one physician who is blinded to the actual antithrombotic treatment given. Radial artery is considered occluded if it exhibits ultrasonographically no antegrade flow signal both at baseline and after reevaluation on a second occasion, within 30 days after the index procedure. Initially patent arteries will not be reexamined and are thought to remain permanently patent. The investigators also monitor major bleeding (defined as ≥ 5g/dL decrease in hemoglobin or ≥15% decrease in hematocrit or any life-threatening bleeding (confirmed by MRI or computed tomography) and large local hematomas of the forearm (defined as those extending beyond the forearm).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard dose of Heparin | Active comparator | Drug: Standard dose of Unfractionated heparin50IU/Kg heparin intravenously |
| High dose of Heparin | Experimental | Drug: High dose of Unfractionated Heparin100IU/Kg heparin intravenously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Older than 18 years old
- Scheduled for 5 or 6 Fr diagnostic coronary angiography
- The interventional cardiologist is willing to proceed with radial access
- Written informed consent
Key exclusion criteria (10 listed)
- Before randomization
- chronic hemodialysis
- oral anticoagulation
- hemodynamic instability
- severe dermo-myoskeletal forearm deformities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High dose of Unfractionated HeparinUnfractionated Heparin 100IU/Kg | Drug | High dose of Heparin |
| Standard dose of Unfractionated heparinUnfractionated heparin 50IU/Kg | Drug | Standard dose of Heparin |
Primary outcome
Radial artery occlusion
Time frame: 30 days
Radial artery occlusion as assessed by Doppler Ultrasound
2 secondary outcomes
Large local hematomas of the forearm
Time frame: 30 days
Major bleeding
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
- Derived from this study: PubMed 30391389Hahalis GN, Leopoulou M, Tsigkas G, Xanthopoulou I, Patsilinakos S, Patsourakos NG, Ziakas A, Kafkas N, Koutouzis M, Tsiafoutis I, Athanasiadis I, Koniari I, Almpanis G, Anastasopoulou M, Despotopoulos S, Kounis N, Dapergola A, Aznaouridis K, Davlouros P. Multicenter Randomized Evaluation of High Versus Standard Heparin Dose on Incident Radial Arterial Occlusion After Transradial Coronary Angiography: The SPIRIT OF ARTEMIS Study. JACC Cardiovasc Interv. 2018 Nov 26;11(22):2241-2250. doi: 10.1016/j.jcin.2018.08.009. Epub 2018 Nov 1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing High dose of Unfractionated Heparin and Standard dose of Unfractionated heparin in people with Coronary Angiography, run by University of Patras at 1 site in Greece.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radial artery occlusion (time frame: 30 days). 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 NCT02570243, 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 19 Sep 2017.