Drug Drug Interactions of Aspirin and P2Y12-inhibitors

Phase 4

Completed

• Conditions: Myocardial Infarction; Drug Interaction Potentiation
• Interventions: Drug: Placebo; Drug: Morphine

• Registration Number: NCT01369186
• Lead Sponsor: Medical University of Vienna

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-06-07
• Study First Submitted QC: 2011-06-07
• Study First Posted: 2011-06-08
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-23
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Sodium chloride 0.9% i.v. bolus injection
Morphine	Morphine	Vendal 5 mg i.v. bolus injection

Primary Outcome Measures

Name	Time	Method
Platelet function	14 days

Secondary Outcome Measures

Name	Time	Method
Tmax	14 days
Cmax	14 days

Trial Locations

Locations (1)

Medical University of Vienna, Department of Clinical Pharmacology; 🇦🇹 Vienna, Austria