Heart DiseaseNCT01365741
Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient
A study testing Upright position in people with Heart Disease and Ischemic Heart Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of the study is to clarify wether body posture during ingestion of 60mg Efient, a thrombocytic inhibitor, has influence on the time to thrombocytic inhibition. The study aims to mimic the treatment Danish patients receive when admitted to the hospital with a ST-elevation myocardial infarction since these… Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Heart Disease, Ischemic Heart Disease, ST-elevation Myocardial Infarction
- What is being tested?
- Upright position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2011to Apr 2016
- Phase
- Interventional
- 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 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20-30 years of age
- Healthy
- Male
- Ability to give informed consent
- Non-Smoker
Who cannot join
- Known with reflux or dysphagia
- Ingestion of medicine, beside Paracetamol <14 prior to the trial
- Hematological diseases
- Diabetes
- Known kidney disease
- Known liver disease
Show all 11Show fewer
- Recent trauma
- Scheduled operation within 7 days after the trial
- Former apoplexia
- Known gastro-intestinal disease
- Weight <60 kg
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to clarify wether body posture during ingestion of 60mg Efient, a thrombocytic inhibitor, has influence on the time to thrombocytic inhibition.
The study aims to mimic the treatment Danish patients receive when admitted to the hospital with a ST-elevation myocardial infarction since these patients are refereed to acute Percutaneous Coronary Intervention (PCI) necessitating fast and efficient thrombocytic inhibition.
Read more
Current guidelines recommend the administration of Efient right before the PCI procedure, while the patient is lying down, either in the ambulance or in the operating room. We, the investigators, believe that this is suboptimal for the patient, since any sort of prolonged inhibition time will possibly worsen the patients prognosis and make the patient more prone to later clotting issues.
Our hypothesis is that by making the patients ingest the tablets in a 90 degrees upright position and making them sit up for 2 minutes after ingestion, the effect of the pills will commence faster than if taken in a supine position. This will possibly lead to faster inhibition of the thrombocytes, which we believe will lead to a lower incidence of clotting issues during and after the procedure.
Read the detailed description
The study will be divided into two sessions: first session will be the control arm- ingestion of Efient in supine position.
14 days later, the same test-persons will be doing the intervention- ingestion of Efient sitting upright for 2 minutes. Besides this, the second session will be exactly the same as the control arm.
- Being tested
- Upright position
- Keywords
- PCI, STEMI, Interventions, Heart disease, Thrombocytic inhibition, Cross-over study, Percutaneous coronary intervention
- Medical subject headings
- Heart Diseases, Myocardial Ischemia, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upright positionOther
Also called Efient, Prasugrel, PCI
The test person will ingest Efient in an upright position and remain upright for 2 minutes. After 2 minutes, the test person will lie down, and remain supine for 2 hours, the same way as the person did in the control arm
| Study group | Role | What they receive |
|---|---|---|
| Standard administration of Efient | No intervention | The test person will ingest Efient in supine position, and remain supine during 2 hours, mimicing the way Efient is used for pre-PCI treatment today |
| Upright administration of Efient | Active comparator | The test person will ingest Efient in an upright position, and remain supine during 2 hours. Receives: Other: Upright position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Inhibition of ADP-receptors on thrombocytes
The primary outcome will be the difference between the time to sufficient/maximal inhibition of the ADP-receptors on the test-persons thrombocytes compared between supine and upright ingestion of Efient.
Inhibition will be verified bedside by VerifyNow analyses.
Measured: Blood will be drawn from the test person at 0, 20, 40, 60, 80, 100minutes post ingestion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startFeb 2011
- Primary completionMar 2016
- Study completionApr 2016
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 Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob Antonsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Jacob Antonsen, MD, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365741
- Sponsor's protocol ID
- TTISUE
- Status last verified
- Apr 2019
- First submitted
- 21 Dec 2010
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Antonsen J, Bundgaard N, Holmvang L, Engstrom T, Iversen K. Posture changes platelet inhibition time after ingestion of prasugrel. Dan Med J. 2018 Oct;65(10):A5504.
PubMed 30269747
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient
- ClinicalTrials.gov ID
- NCT01365741
- Acronym / sponsor ID
- TTISUE
- Keywords
- PCI, STEMI, Interventions, Heart disease, Thrombocytic inhibition, Cross-over study, Percutaneous coronary intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 3 Jun 2011 (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.
The purpose of the study is to clarify wether body posture during ingestion of 60mg Efient, a thrombocytic inhibitor, has influence on the time to thrombocytic inhibition.
The study aims to mimic the treatment Danish patients receive when admitted to the hospital with a ST-elevation myocardial infarction since these patients are refereed to acute Percutaneous Coronary Intervention (PCI) necessitating fast and efficient thrombocytic inhibition.
Current guidelines recommend the administration of Efient right before the PCI procedure, while the patient is lying down, either in the ambulance or in the operating room. We, the investigators, believe that this is suboptimal for the patient, since any sort of prolonged inhibition time will possibly worsen the patients prognosis and make the patient more prone to later clotting issues.
Our hypothesis is that by making the patients ingest the tablets in a 90 degrees upright position and making them sit up for 2 minutes after ingestion, the effect of the pills will commence faster than if taken in a supine position. This will possibly lead to faster inhibition of the thrombocytes, which we believe will lead to a lower incidence of clotting issues during and after the procedure.
Detailed description
The study will be divided into two sessions: first session will be the control arm- ingestion of Efient in supine position.
14 days later, the same test-persons will be doing the intervention- ingestion of Efient sitting upright for 2 minutes. Besides this, the second session will be exactly the same as the control arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard administration of Efient | No intervention | –The test person will ingest Efient in supine position, and remain supine during 2 hours, mimicing the way Efient is used for pre-PCI treatment today |
| Upright administration of Efient | Active comparator | Other: Upright positionThe test person will ingest Efient in an upright position, and remain supine during 2 hours. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 20-30 years of age
- Healthy
- Male
- Ability to give informed consent
- Non-Smoker
Key exclusion criteria (11 listed)
- Known with reflux or dysphagia
- Ingestion of medicine, beside Paracetamol <14 prior to the trial
- Hematological diseases
- Diabetes
- Known kidney disease
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 |
|---|---|---|
| Upright positionAlso: Efient, Prasugrel, PCIThe test person will ingest Efient in an upright position and remain upright for 2 minutes. After 2 minutes, the test person will lie down, and remain supine for 2 hours, the same way as the person did in the control arm | Other | Upright administration of Efient |
Primary outcome
Change in Inhibition of ADP-receptors on thrombocytes
Time frame: Blood will be drawn from the test person at 0, 20, 40, 60, 80, 100minutes post ingestion.
The primary outcome will be the difference between the time to sufficient/maximal inhibition of the ADP-receptors on the test-persons thrombocytes compared between supine and upright ingestion of Efient. Inhibition will be verified bedside by VerifyNow analyses.
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 16 Apr 2019.
- Derived from this study: PubMed 30269747Antonsen J, Bundgaard N, Holmvang L, Engstrom T, Iversen K. Posture changes platelet inhibition time after ingestion of prasugrel. Dan Med J. 2018 Oct;65(10):A5504.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Jacob Antonsen, MD principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upright position in people with Heart Disease and Ischemic Heart Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 16 Apr 2019. 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 Denmark. 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.
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?
Change in Inhibition of ADP-receptors on thrombocytes (time frame: Blood will be drawn from the test person at 0, 20, 40, 60, 80, 100minutes post ingestion.). 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 NCT01365741, 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 16 Apr 2019.