Evaluation of Ticagrelor Pharmacokinetics in Patients With Non-ST Elevation Myocardial Infarction After a 180 mg Ticagrelor Loading Dose
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Tmax ticagrelor
研究概览
简要总结
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 ticagrelor. However, the drug uptake after an oral dose of 180mg ticagrelor has not been thoroughly studied in these patients.
The present study will evaluate ticagrelor uptake and platelet aggregation after a 180 mg loading dose ticagrelor in these patients.
详细描述
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 intervention in routine medical treatment.
Patients with non-ST elevation myocardial infarction (NSTEMI) are common, but the pharmacokinetic properties of ticagrelor in the acute phase have, to the best of our knowledge, not been thoroughly studied in these patients.
The present study will evaluate ticagrelor uptake and platelet aggregation after a 180 mg loading dose ticagrelor in NSTEMI patients and compare results with a control group of patients with stable coronary artery disease.
Hypotheses/questions The stress reaction from suffering an NSTEMI causes delayed absorption and possibly delayed and lowered maximal plasma concentrations after a loading dose ticagrelor and thus a delayed and possibly impaired inhibition of platelet aggregation.
Method Study population Subjects eligible for the study will be ticagrelor naïve patients with NSTEMI presenting at the emergency room at Södersjukhuset. Upon arrival to the emergency room written informed consent will be obtained before the patients receive their 180 mg loading dose of ticagrelor if the responsible physician choses this therapy. Inclusion criteria: 1) a diagnosis of NSTEMI (i.e relevant symptoms associated with ischemic ECG changes (not categorized as STEMI) and/or relevantly increased cardiac markers); 2) an indication for a 180 mg ticagrelor loading dose.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
NSTEMI patients
Subjects eligible for the study will be ticagrelor naïve patients with NSTEMI presenting at the emergency room. Upon arrival to the emergency room written informed consent will be obtained before the patients receive their 180 mg loading dose of ticagrelor, as prescribed by the responsible physician.
干预措施: Ticagrelor (Drug)
SCAD controls
Patients with stable coronary artery disease (SCAD) planned for elective angiography. If PCI is to be performed and if the responsible physician decides to administrate a loading dose of 180 mg ticagrelor, written informed consent will be obtained before loading dose and blood sampling.
干预措施: Ticagrelor (Drug)
结局指标
主要结局
Tmax ticagrelor
时间窗: Within 6 hours after oral intake
Time to maximum concentration (Tmax) of ticagrelor after a 180 mg loading dose.
次要结局
- Pharmacodynamic response(Predose, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post dose.)
- Tmax AR-C124910XX(Within 6 hours after oral intake)
- HPR at 2 hours(2 hours after oral intake)
研究者
Jan van der Linden
Professor
Karolinska University Hospital