Status:
COMPLETED
Ticagrelor Pharmacokinetics in NSTEMI
Lead Sponsor:
Karolinska University Hospital
Collaborating Sponsors:
AstraZeneca
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Brief Summary
Patients with myocardial infarction, which does not include all layers of the heart's muscle wall are common and they often receive pharmacological treatment with the platelet inhibiting drug ticagrel...
Detailed Description
This study is to be considered as an observational prospective case-controlled study, according to the Swedish Medical Product Agency (MPA), in response to our enquiry. This is due to lack of interven...
Eligibility Criteria
Inclusion
- A diagnosis of NSTEMI (i.e relevant symptoms associated with ischemic ECG changes (not categorized as STEMI) and/or relevantly increased cardiac markers);
- An indication for a 180 mg ticagrelor loading dose.
Exclusion
- Ticagrelor contraindication, including
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
- Active pathological bleeding
- History of intracranial haemorrhage
- Moderate to severe hepatic impairment.
- Co-administration of ticagrelor with strong CYP3A4 inhibitors (e.g., ketoconazole,clarithromycin, nefazodone, ritonavir, and atazanavir) is contraindicated, as co-administration may lead to a substantial increase in exposure to ticagrelor
- Age \<18 years
- Administration of ticagrelor during the week before inclusion
- Treatment with glycoprotein IIb/IIIa antagonists within 48 hours before inclusion
- Ongoing morphine treatment. However, if patients with NSTEMI without morphine treatment are rare, this exclusion criterion of the protocol may have to be re-evaluated.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT02292277
Start Date
October 1 2014
End Date
January 1 2016
Last Update
May 23 2016
Active Locations (1)
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1
Södersjukhuset
Stockholm, Sweden, 118 83