Primary Percutaneous Coronary InterventionPhase 4PENNY PCINCT03146858
Prolonged Enoxaparin In Primary Percutaneous Coronary Intervention; A Pilot Pharmacodynamic Study
A Phase 4 study testing Enoxaparin in people with Primary Percutaneous Coronary Intervention, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Heart attacks are caused by a clot blocking one or more of the heart arteries (coronary arteries). When complete blockage of one of the arteries occurs, emergency treatment to unblock the affected artery and rescue the heart muscle at risk is essential. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Percutaneous Coronary Intervention
- What is being tested?
- Enoxaparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Aug 2017to 30 Mar 2018
- 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
- Age ≥ 18
- Confirmation of the diagnosis of STEMI by the clinical team on the basis of history, ECG changes and angiographic findings
- Pre-treatment with either ticagrelor or prasugrel
- Intention to proceed with PPCI
- Feasibility to obtain informed verbal consent pre PPCI
Who cannot join
- Active bleeding that cannot be controlled by local measures
- Female patients of child bearing age who have not had a sterilisation procedure
- Patients with end stage renal failure requiring renal replacement therapy
- Known thrombocytopenia (Platelet count < 100,000/μL)
- Known history of intracranial haemorrhage
- Known current treatment with oral anticoagulants
Show all 11Show fewer
- Known history of major surgery or trauma or history of GI/GU haemorrhage within the last month
- Known intracranial malignancy or aneurysm
- Known allergy to enoxaparin
- Inability to easily understand verbal information given in English for any reason
- Inability to give informed consent due to either temporary or permanent mental incapacity
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, S5 7AU
About this study
Heart attacks are caused by a clot blocking one or more of the heart arteries (coronary arteries). When complete blockage of one of the arteries occurs, emergency treatment to unblock the affected artery and rescue the heart muscle at risk is essential. This is usually achieved by performing an emergency procedure called primary percutaneous coronary intervention (PPCI).
Anticlotting treatment is also necessary to reduce the chances of further heart attacks. As part of standard care, tablets that target small cells called platelets (central to blood clot formation) are given as soon as an acute heart attack is suspected. These tablets include aspirin and ticagrelor/prasufrel. Although both ticgrelor and prasugrel are effective, the onset of action is delayed by up to 8 hours when given in context of an acute heart attack. This delay in onset of action can increase the risk of further heart attacks.
Read more
Enoxaparin is an anticlotting treatment that targets the other aspect of clot formation known as coagulation cascade. Enoxaparin or an alternative is recommended as a single does to support the PPCI procedure. The effects of a single shot of enoxaparin do not last long enough to bridge the gap in anticlotting treatment caused by the delayed action of ticagrelor/prasugrel. Since the investigators have realised the delayed onset of action of tablet therapy, the investigators have been using another drug called tirofiban as a drip. Tirofiban blocks platelets effectively, but greatly increases the risk of bleeding events.
The investigators believe that giving enoxaparin as a drip for 3-6 hours (following the single dose) instead of tirofiban, would be sufficient to bridge the gap in anticlotting effect without greatly increasing the risk of bleeding. This is a pilot study to assess the effects of enoxaparin drip in patients presenting with acute heart attacks and undergoing emergency treatment with PPCI.
Read the detailed description
This is a single centre, pharmacodynamic pilot study of a prolonged enoxaparin infusion following the guideline directed bolus treatment in patients undergoing PPCI conducted at Sheffield Teaching Hospitals NHS Foundation Trust.
Patients admitted to the catheter laboratory or coronary care unit with STEMI and accepted for PPCI will be screened. Those meeting the inclusion criteria will be recruited following angiography. Aspirin is usually administered in the ambulance prior to patient's arrival to hospital and ticagrelor or prasugrel is given as soon as possible on arrival to hospital. This is part of standard clinical care.
The proposed anticoagulant intervention is a parenteral (intra-arterial or intravenous; IA/IV) bolus dose of enoxaparin (0.5 mg/kg) at the time of PPCI followed by an infusion of 0.5 mg/kg over a 6-hour period. In patients with impaired kidney function (eGFR < 30 ml/min), the infusion will be stopped at 3 hours (cumulative dose of 0.75 mg/kg).
Blood samples for anti Xa activity, VerifyNow P2Y12 assay and fibrin clot dynamics will be collected at the following time points:
- Time point 1 (T1) prior to anticoagulation - at the start of PCI procedure.
- Time point 2 (T2) at the end of PPCI.
- Time point 3 (T3) 2-3 hours from the start of enoxaparin infusion.
- Time point 4 (T4) at the end of enoxaparin infusion. In patients with impaired kidney function (eGFR < 30 ml/min), T3 will be the last blood sample taken (at the end of the infusion).
As PPCI is time critical and delay in treatment can be detrimental to clinical outcome, informed written consent will not be possible prior to the procedure. However, verbal consent using an abbreviated patient information sheet will be obtained prior to enrolment. This will be clearly documented in the patient hospital notes and CRF. As soon as possible after the procedure and whenever possible prior to obtaining T3 blood sample, full written informed consent will be obtained. Blood sampling for T1 and T2 will be done through the arterial sheath and therefore should not cause any significant delay or distress. In the unlikely event where a participant deteriorates and loses capacity during the study, they will be withdrawn from the study but data and blood samples obtained with consent will be retained in the study. In such a case, the treating cardiologist will decide whether to continue with the enoxaparin infusion or not. The consent process will be performed by a qualified medical practitioner according to the principles of Good Clinical Practice (GCP) and the declaration of Helsinki. Following consent, details of patient participation will be sent to their general practitioner.
Clinical outcomes and adverse events will be recorded 12 hours after the end PCI or at the time of transfer to another hospital, whichever comes first. The half-life of enoxaparin is 1-2 hours when given intravenously, and therefore, adverse events are unlikely to arise following the proposed follow-up period.
The primary objective is to assess the pharmacodynamic effect of a prolonged enoxaparin infusion in the context of PPCI. This will be achieved by serial measurements of anti Xa activity.
For inclusion in the study, subjects should fulfil the following criteria:
- Age ≥ 18
- Confirmation of the diagnosis of STEMI by the clinical team on the basis of history, ECG changes and angiographic findings
- Pre-treatment with either ticagrelor or prasugrel
- Intention to proceed with PPCI
- Feasibility to obtain informed verbal consent pre PPCI
Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
- Active bleeding that cannot be controlled by local measures
- Female patients of child bearing age who have not had a sterilisation procedure
- Patients with end stage renal failure requiring renal replacement therapy
- Known thrombocytopenia (Platelet count < 100,000/μL)
- Known history of intracranial haemorrhage
- Known current treatment with oral anticoagulants
- Known history of major surgery or trauma or history of GI/GU haemorrhage within the last month
- Known intracranial malignancy or aneurysm
- Known allergy to enoxaparin
- Inability to easily understand verbal information given in English for any reason
- Inability to give informed consent due to either temporary or permanent mental incapacity
- Being tested
- Enoxaparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
Enoxaparin is an anticlotting treatment that targets the other aspect of clot formation known as the coagulation cascade. Enoxaparin or an alternative is recommended as a single does to support PPCI procedure.
| Study group | Role | What they receive |
|---|---|---|
| Enoxaparin | Experimental | The patients will receive a 3-6 hour infusion of enoxaparin. The effects of the infusion will be assess when used on patients will acute heart attacks and undergoing emergency treatment with PPCI. Receives: Drug: Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
anti Xa activity change
To assess the pharmacodynamic effect of a prolonged enoxaparin infusion in the context.of PPCI. This will be achieved by serial measurements of anti Xa activity.
Measured: recruitment, baseline, 3 hrs from baseline, 6 hrs from baseline
Secondary outcomes (3)
P2Y12 Inhibition change
Assess the level of P2Y12 inhibition in response to oral therapy. This will be achieved by performing the established VerifyNow P2Y12 assay. Although the delay in platelet inhibition is well established now, measuring P2Y12 inhibition is valuable in this case to ensure that adequate inhibition is achieved by the end of enoxaparin infusion. It would also provide useful information in case of complications such as stent thrombosis or bleeding.
Measured: recruitment, baseline, 3 hrs from baseline, 6 hrs from baseline
Fibrin Clot Formation change
Assess the effects of the proposed regimen on fibrin clot formation. This will be done by thromboelastography (TEG) in whole blood and by turbidimetric assay in plasma
Measured: recruitment, baseline, 3 hrs from baseline, 6 hrs from baseline
Enoxaparin Regimen
Obtain pilot data on the safety of the enoxaparin regimen by assessing bleeding rates 12 hours following PCI
Measured: within 12 hours from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start25 Aug 2017
- Primary completion30 Dec 2017
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Primary Percutaneous Coronary InterventionStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Once patients have been recruited into the trail, they will undertake the first of 4 blood samples. Following the samples the PPCI treatment with begin. The enoxaparin infusion will be set up when the treatment begins. At the end of the PPCI treatment the second blood sample will obtained. The enoxaparin infusion will be commenced after a kidney function check has been performed. The third blood sample will be taken 3 hours into the infusion, and the 4th sample taken at the end of the 6 hour infusion. A 12 hour clinical follow up will then be performed and will mark study completion for the patient.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146858
- Sponsor's protocol ID
- STH19752
- Acronym
- PENNY PCI
- Status last verified
- Apr 2018
- First submitted
- 27 Mar 2017
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karunakaran A, Sumaya W, Gunn JP, Morton AC, Storey RF. Contemporary management of ST-segment elevation myocardial infarction. Hosp Pract (1995). 2012 Feb;40(1):224-31. doi: 10.3810/hp.2012.02.963.
PubMed 22406898Huynh T, Perron S, O'Loughlin J, Joseph L, Labrecque M, Tu JV, Theroux P. Comparison of primary percutaneous coronary intervention and fibrinolytic therapy in ST-segment-elevation myocardial infarction: bayesian hierarchical meta-analyses of randomized controlled trials and observational studies. Circulation. 2009 Jun 23;119(24):3101-9. doi: 10.1161/CIRCULATIONAHA.108.793745. Epub 2009 Jun 8.
PubMed 19506117Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology (ESC); Steg PG, James SK, Atar D, Badano LP, Blomstrom-Lundqvist C, Borger MA, Di Mario C, Dickstein K, Ducrocq G, Fernandez-Aviles F, Gershlick AH, Giannuzzi P, Halvorsen S, Huber K, Juni P, Kastrati A, Knuuti J, Lenzen MJ, Mahaffey KW, Valgimigli M, van 't Hof A, Widimsky P, Zahger D. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J. 2012 Oct;33(20):2569-619. doi: 10.1093/eurheartj/ehs215. Epub 2012 Aug 24. No abstract available.
PubMed 22922416
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Enoxaparin In Primary Percutaneous Coronary Intervention; A Pilot Pharmacodynamic Study
- ClinicalTrials.gov ID
- NCT03146858
- Acronym / sponsor ID
- PENNY PCI / STH19752
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 25 Aug 2017 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 10 May 2017 (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.
Heart attacks are caused by a clot blocking one or more of the heart arteries (coronary arteries). When complete blockage of one of the arteries occurs, emergency treatment to unblock the affected artery and rescue the heart muscle at risk is essential. This is usually achieved by performing an emergency procedure called primary percutaneous coronary intervention (PPCI).
Anticlotting treatment is also necessary to reduce the chances of further heart attacks. As part of standard care, tablets that target small cells called platelets (central to blood clot formation) are given as soon as an acute heart attack is suspected. These tablets include aspirin and ticagrelor/prasufrel. Although both ticgrelor and prasugrel are effective, the onset of action is delayed by up to 8 hours when given in context of an acute heart attack. This delay in onset of action can increase the risk of further heart attacks.
Enoxaparin is an anticlotting treatment that targets the other aspect of clot formation known as coagulation cascade. Enoxaparin or an alternative is recommended as a single does to support the PPCI procedure. The effects of a single shot of enoxaparin do not last long enough to bridge the gap in anticlotting treatment caused by the delayed action of ticagrelor/prasugrel. Since the investigators have realised the delayed onset of action of tablet therapy, the investigators have been using another drug called tirofiban as a drip. Tirofiban blocks platelets effectively, but greatly increases the risk of bleeding events.
The investigators believe that giving enoxaparin as a drip for 3-6 hours (following the single dose) instead of tirofiban, would be sufficient to bridge the gap in anticlotting effect without greatly increasing the risk of bleeding. This is a pilot study to assess the effects of enoxaparin drip in patients presenting with acute heart attacks and undergoing emergency treatment with PPCI.
Detailed description
This is a single centre, pharmacodynamic pilot study of a prolonged enoxaparin infusion following the guideline directed bolus treatment in patients undergoing PPCI conducted at Sheffield Teaching Hospitals NHS Foundation Trust.
Patients admitted to the catheter laboratory or coronary care unit with STEMI and accepted for PPCI will be screened. Those meeting the inclusion criteria will be recruited following angiography. Aspirin is usually administered in the ambulance prior to patient's arrival to hospital and ticagrelor or prasugrel is given as soon as possible on arrival to hospital. This is part of standard clinical care.
The proposed anticoagulant intervention is a parenteral (intra-arterial or intravenous; IA/IV) bolus dose of enoxaparin (0.5 mg/kg) at the time of PPCI followed by an infusion of 0.5 mg/kg over a 6-hour period. In patients with impaired kidney function (eGFR < 30 ml/min), the infusion will be stopped at 3 hours (cumulative dose of 0.75 mg/kg).
Blood samples for anti Xa activity, VerifyNow P2Y12 assay and fibrin clot dynamics will be collected at the following time points:
- Time point 1 (T1) prior to anticoagulation - at the start of PCI procedure.
- Time point 2 (T2) at the end of PPCI.
- Time point 3 (T3) 2-3 hours from the start of enoxaparin infusion.
- Time point 4 (T4) at the end of enoxaparin infusion. In patients with impaired kidney function (eGFR < 30 ml/min), T3 will be the last blood sample taken (at the end of the infusion).
As PPCI is time critical and delay in treatment can be detrimental to clinical outcome, informed written consent will not be possible prior to the procedure. However, verbal consent using an abbreviated patient information sheet will be obtained prior to enrolment. This will be clearly documented in the patient hospital notes and CRF. As soon as possible after the procedure and whenever possible prior to obtaining T3 blood sample, full written informed consent will be obtained. Blood sampling for T1 and T2 will be done through the arterial sheath and therefore should not cause any significant delay or distress. In the unlikely event where a participant deteriorates and loses capacity during the study, they will be withdrawn from the study but data and blood samples obtained with consent will be retained in the study. In such a case, the treating cardiologist will decide whether to continue with the enoxaparin infusion or not. The consent process will be performed by a qualified medical practitioner according to the principles of Good Clinical Practice (GCP) and the declaration of Helsinki. Following consent, details of patient participation will be sent to their general practitioner.
Clinical outcomes and adverse events will be recorded 12 hours after the end PCI or at the time of transfer to another hospital, whichever comes first. The half-life of enoxaparin is 1-2 hours when given intravenously, and therefore, adverse events are unlikely to arise following the proposed follow-up period.
The primary objective is to assess the pharmacodynamic effect of a prolonged enoxaparin infusion in the context of PPCI. This will be achieved by serial measurements of anti Xa activity.
For inclusion in the study, subjects should fulfil the following criteria:
- Age ≥ 18
- Confirmation of the diagnosis of STEMI by the clinical team on the basis of history, ECG changes and angiographic findings
- Pre-treatment with either ticagrelor or prasugrel
- Intention to proceed with PPCI
- Feasibility to obtain informed verbal consent pre PPCI
Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
- Active bleeding that cannot be controlled by local measures
- Female patients of child bearing age who have not had a sterilisation procedure
- Patients with end stage renal failure requiring renal replacement therapy
- Known thrombocytopenia (Platelet count < 100,000/μL)
- Known history of intracranial haemorrhage
- Known current treatment with oral anticoagulants
- Known history of major surgery or trauma or history of GI/GU haemorrhage within the last month
- Known intracranial malignancy or aneurysm
- Known allergy to enoxaparin
- Inability to easily understand verbal information given in English for any reason
- Inability to give informed consent due to either temporary or permanent mental incapacity
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Once patients have been recruited into the trail, they will undertake the first of 4 blood samples. Following the samples the PPCI treatment with begin. The enoxaparin infusion will be set up when the treatment begins. At the end of the PPCI treatment the second blood sample will obtained. The enoxaparin infusion will be commenced after a kidney function check has been performed. The third blood sample will be taken 3 hours into the infusion, and the 4th sample taken at the end of the 6 hour infusion. A 12 hour clinical follow up will then be performed and will mark study completion for the patient.
| Arm | Type | Receives |
|---|---|---|
| Enoxaparin | Experimental | Drug: EnoxaparinThe patients will receive a 3-6 hour infusion of enoxaparin. The effects of the infusion will be assess when used on patients will acute heart attacks and undergoing emergency treatment with PPCI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18
- Confirmation of the diagnosis of STEMI by the clinical team on the basis of history, ECG changes and angiographic findings
- Pre-treatment with either ticagrelor or prasugrel
- Intention to proceed with PPCI
- Feasibility to obtain informed verbal consent pre PPCI
Key exclusion criteria (11 listed)
- Active bleeding that cannot be controlled by local measures
- Female patients of child bearing age who have not had a sterilisation procedure
- Patients with end stage renal failure requiring renal replacement therapy
- Known thrombocytopenia (Platelet count < 100,000/μL)
- Known history of intracranial haemorrhage
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 |
|---|---|---|
| EnoxaparinEnoxaparin is an anticlotting treatment that targets the other aspect of clot formation known as the coagulation cascade. Enoxaparin or an alternative is recommended as a single does to support PPCI procedure. | Drug | Enoxaparin |
Primary outcome
anti Xa activity change
Time frame: recruitment, baseline, 3 hrs from baseline, 6 hrs from baseline
To assess the pharmacodynamic effect of a prolonged enoxaparin infusion in the context.of PPCI. This will be achieved by serial measurements of anti Xa activity.
3 secondary outcomes
P2Y12 Inhibition change
Time frame: recruitment, baseline, 3 hrs from baseline, 6 hrs from baseline
Fibrin Clot Formation change
Time frame: recruitment, baseline, 3 hrs from baseline, 6 hrs from baseline
Enoxaparin Regimen
Time frame: within 12 hours from baseline
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 Apr 2018.
- Results publication: PubMed 22406898Karunakaran A, Sumaya W, Gunn JP, Morton AC, Storey RF. Contemporary management of ST-segment elevation myocardial infarction. Hosp Pract (1995). 2012 Feb;40(1):224-31. doi: 10.3810/hp.2012.02.963.
- Results publication: PubMed 19506117Huynh T, Perron S, O'Loughlin J, Joseph L, Labrecque M, Tu JV, Theroux P. Comparison of primary percutaneous coronary intervention and fibrinolytic therapy in ST-segment-elevation myocardial infarction: bayesian hierarchical meta-analyses of randomized controlled trials and observational studies. Circulation. 2009 Jun 23;119(24):3101-9. doi: 10.1161/CIRCULATIONAHA.108.793745. Epub 2009 Jun 8.
- Results publication: PubMed 22922416Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology (ESC); Steg PG, James SK, Atar D, Badano LP, Blomstrom-Lundqvist C, Borger MA, Di Mario C, Dickstein K, Ducrocq G, Fernandez-Aviles F, Gershlick AH, Giannuzzi P, Halvorsen S, Huber K, Juni P, Kastrati A, Knuuti J, Lenzen MJ, Mahaffey KW, Valgimigli M, van 't Hof A, Widimsky P, Zahger D. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J. 2012 Oct;33(20):2569-619. doi: 10.1093/eurheartj/ehs215. Epub 2012 Aug 24. No abstract available.
- Individual participant dataSharing planned: No
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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 Enoxaparin in people with Primary Percutaneous Coronary Intervention, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 5 inclusion and 11 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 Apr 2018. 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 United Kingdom. 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?
anti Xa activity change (time frame: recruitment, baseline, 3 hrs from baseline, 6 hrs from baseline). 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 NCT03146858, which also lists 3 linked publications.
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 Apr 2018.