Ischemic Heart Disease Clinical Trial
Official title:
Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient
NCT number | NCT01365741 |
Other study ID # | TTISUE |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2011 |
Est. completion date | April 2016 |
Verified date | April 2019 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | April 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 20 Years to 30 Years |
Eligibility |
Inclusion Criteria: - 20-30 years of age - Healthy - Male - Ability to give informed consent - Non-Smoker Exclusion Criteria: - Known with reflux or dysphagia - Ingestion of medicine, beside Paracetamol <14 prior to the trial - Hematological diseases - Diabetes - Known kidney disease - Known liver disease - Recent trauma - Scheduled operation within 7 days after the trial - Former apoplexia - Known gastro-intestinal disease - Weight <60 kg |
Country | Name | City | State |
---|---|---|---|
Denmark | Nordsjællands Hospital | Hillerød |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
Blood will be drawn from the test person at 0, 20, 40, 60, 80, 100minutes post ingestion. |
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