Drug Drug Interactions of Aspirin and P2Y12-inhibitors

This study is currently recruiting participants.

Verified May 2013 by Medical University of Vienna

Sponsor:

Information provided by (Responsible Party):

Eva-Luise Hobl, Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT01369186

First received: June 7, 2011

Last updated: May 21, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

June 7, 2011

Last Updated Date

May 21, 2013

Start Date ^ICMJE

May 2011

Estimated Primary Completion Date

May 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Platelet function [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01369186 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Tmax [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Cmax [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Drug Drug Interactions of Aspirin and P2Y12-inhibitors

Official Title ^ICMJE

Drug Drug Interactions of Antiplatelet Drugs and Morphine

Brief Summary

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

VA Drug Interactions [VA Drug Interaction]
Myocardial Infarction

Intervention ^ICMJE

Drug: Morphine
i.v. bolus injection

Other Name: Vendal
Drug: Placebo
i.v. bolus injection

Other Name: Sodium chloride 0,9%

Study Arm (s)

Active Comparator: Morphine
Intervention: Drug: Morphine
Placebo Comparator: Placebo
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

May 2014

Estimated Primary Completion Date

May 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Bernd Jilma, Prof. Dr.	43 1 40400 ext 2981	bernd.jilma@meduniwien.ac.at
Contact: Eva-Luise Hobl, Dr.	43 1 40400 ext 2981	eva-luise.hobl@meduniwien.ac.at

Location Countries ^ICMJE

Austria

Administrative Information

NCT Number ^ICMJE

NCT01369186

Other Study ID Numbers ^ICMJE

2010-023761-22

Has Data Monitoring Committee

Responsible Party

Eva-Luise Hobl, Medical University of Vienna

Study Sponsor ^ICMJE

Medical University of Vienna

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Medical University of Vienna

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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