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Drug Drug Interactions of Aspirin and P2Y12-inhibitors

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Medical University of Vienna

Status and phase

Completed
Phase 4

Conditions

Drug Interaction Potentiation
Myocardial Infarction

Treatments

Drug: Morphine
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01369186
2010-023761-22

Details and patient eligibility

About

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

Full 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.

Enrollment

95 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

95 participants in 2 patient groups, including a placebo group

Morphine
Active Comparator group
Description:
Vendal 5 mg i.v. bolus injection
Treatment:
Drug: Morphine
Placebo
Placebo Comparator group
Description:
Sodium chloride 0.9% i.v. bolus injection
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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