Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient

Ischemic Heart Disease Clinical Trial

Official title:

Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01365741
• Other study ID #: TTISUE
• Status: Completed
• Phase: N/A
• Start date: February 2011
• Est. completion date: April 2016

Study information

• Verified date: April 2019
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Disease
• Heart Diseases
• Infarction
• Ischemic Heart Disease
• Myocardial Infarction
• Myocardial Ischemia
• ST Elevation Myocardial Infarction
• ST-elevation Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
Denmark	Nordsjællands Hospital	Hillerød

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

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.

External Links

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