Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient - Full Text View

Purpose

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.

Condition	Intervention
Heart Disease Ischemic Heart Disease ST-elevation Myocardial Infarction	Other: Upright position


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack Heart Diseases

Drug Information available for: Prasugrel

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

Change in Inhibition of ADP-receptors on thrombocytes [ Time Frame: Blood will be drawn from the test person at 0, 20, 40, 60, 80, 100, 120 minutes post ingestion. ] [ Designated as safety issue: No ]
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.


Enrollment:	10
Study Start Date:	February 2011
Study Completion Date:	April 2016
Primary Completion Date:	March 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Standard administration of Efient 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
Active Comparator: Upright administration of Efient The test person will ingest Efient in an upright position, and remain supine during 2 hours.	Other: Upright position 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 Other Names: Efient Prasugrel PCI

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.

Eligibility


Ages Eligible for Study:	20 Years to 30 Years (Adult)
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01365741

Locations


Denmark
Nordsjællands Hospital
Hillerød, Denmark, 2100

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators


Principal Investigator:	Jacob Antonsen, MD	Bispebjerg Hospital

More Information


Responsible Party:	Jacob Antonsen, Medical Doctor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT01365741 History of Changes
Other Study ID Numbers:	TTISUE
Study First Received:	December 21, 2010
Last Updated:	April 9, 2016
Health Authority:	Denmark: The Regional Committee on Biomedical Research Ethics Denmark: Danish Dataprotection Agency
Individual Participant Data
Plan to Share IPD:	Undecided

Keywords provided by Rigshospitalet, Denmark:


PCI STEMI Interventions Heart disease	Thrombocytic inhibition Cross-over study Percutaneous coronary intervention

Additional relevant MeSH terms:


Infarction Heart Diseases Myocardial Infarction Myocardial Ischemia Coronary Artery Disease Ischemia Pathologic Processes Necrosis	Cardiovascular Diseases Vascular Diseases Coronary Disease Arteriosclerosis Arterial Occlusive Diseases Prasugrel Hydrochloride Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on September 27, 2016