Drug Drug Interactions of Aspirin and P2Y12-inhibitors

Myocardial Infarction Clinical Trial

Official title:

Drug Drug Interactions of Antiplatelet Drugs and Morphine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01369186
• Other study ID #: 2010-023761-22
• Status: Completed
• Phase: Phase 4
• First received: June 7, 2011
• Last updated: March 23, 2017
• Start date: May 2011
• Est. completion date: January 2015

Study information

• Verified date: March 2017
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study Objective: To investigate potential drug-drug interactions (pharmacokinetics and pharmacodynamics) of morphine and antiplatelet drugs (aspirin, clopidogrel, prasugrel, ticagrelor)

Description:

Rationale: Opiates reduce the intestinal resorption of orally administered drugs such as paracetamol. Because morphine is often injected to relieve pain in patients with myocardial infarction, it is of particular interest if morphine may decrease the rate of absorption of antiplatelet drugs. Results of this study will provide essential information for the use of morphine and antiplatelet drugs in clinical practice, in particular in myocardial infarction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy volunteers = 18 years of age

• No intake of NSARs and P2Y12-inhibitors within 14 days before study entry

• Written informed consent

Exclusion Criteria:

• Known coagulation disorders

• Relevant impairment of hepatic function (elevated transaminases, = 2 fold)

• Relevant impairment of renal function

• Infectious diseases (HIV, hepatitis B and C)

• Gestation and lactation

• Clinically relevant abnormal laboratory values

• Use of medication during 2 weeks before the start of the study, which may affect the validity of the study

• General contraindications for aspirin (resp. clopidogrel, prasugrel, ticagrelor) and morphine

Related Conditions & MeSH terms

• Drug Interaction Potentiation
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Morphine
i.v. bolus injection
• Placebo
i.v. bolus injection

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Department of Clinical Pharmacology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (2)

Hobl EL, Schmid RW, Stimpfl T, Ebner J, Jilma B. Absorption kinetics of low-dose chewable aspirin--implications for acute coronary syndromes. Eur J Clin Invest. 2015 Jan;45(1):13-7. doi: 10.1111/eci.12373. — View Citation

Hobl EL, Stimpfl T, Ebner J, Schoergenhofer C, Derhaschnig U, Sunder-Plassmann R, Jilma-Stohlawetz P, Mannhalter C, Posch M, Jilma B. Morphine decreases clopidogrel concentrations and effects: a randomized, double-blind, placebo-controlled trial. J Am Coll Cardiol. 2014 Feb 25;63(7):630-5. doi: 10.1016/j.jacc.2013.10.068. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet function		14 days
Secondary	Tmax		14 days
Secondary	Cmax		14 days