Clinical trial NCT01636180: Effect of the Repeated Loading Dose of Clopidogrel and High Dose of Clopidogrel Continuous Therapy on the Platelet Aggregation Inhibition in Patients With Myocardial Infarction Undergoing Interventional Treatment.
Official title: Effect of the Repeated Loading Dose of Clopidogrel and High Dose of Clopidogrel Continuous Therapy on the Platelet Aggregation Inhibition in Patients With Myocardial Infarction Undergoing Interventional Treatment.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Acute Myocardial Infarction
Keywords: STEMI
NSTEMI
clopidogrel
Areplex
REL-0609
Lead sponsor: Fundacja Ośrodek Badań Medycznych
Sponsor class: OTHER
Collaborators: name: KCRI
First posted: 2012-07-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: REL-0609 trial's hypothesis is that repeated loading doses of clopidogrel (600 mg) administration in addition to high dose of clopidogrel continuous therapy (150 mg/day) results in higher inhibition of the platelets' aggregation in patients with myocardial infarction undergoing interventional treatment comparing to the standard therapy. Such treatment strategy will not cause increased risk of bleeding complications. In many trials treatment with to repeated loading doses of clopidogrel together with high dose of clopidogrel continuous therapy resulted in: MACE reduction, improvement of the long term therapy results, lower risk of ischemic complications. Currently, data regarding to the results of the above treatment are still limited.

Detailed description: The objectives of the study is:

* to evaluate the effect of the repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy (150 mg/day) on the platelet aggregation inhibition in patients with myocardial infarction undergoing interventional treatment
* to evaluate the safety of the repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy (150 mg/day) in patients with myocardial infarction undergoing interventional treatment

Eligibility criteria: Inclusion Criteria:

•≥18 years of age,

* Myocardial Infarction with or without ST segment elevation,
* clopidogrel treatment (confirmed administration of loading dose of 600 mg or chronic therapy of 75 mg/day),
* signed written informed consent.

Exclusion Criteria:

* prior administration of fibrinolytic therapy and/or GP IIb/IIIa inhibitors within the last 14 days,
* prior administration of prasugrel within the last 14 days,
* subject with known hypersensitivity to the active ingredient or other components of the product
* increased risk of bleeding complications:bleeding diathesis, thrombocytopenia (platelet count \< 100 000/mm3), oral anticoagulant therapy (INR \>1.6), uncontrolled hypertension (systolic blood pressure \>200 mmHg), major bleeding, trauma or surgery within the last 30 days,
* acute renal failure,
* acute liver failure,
* pregnancy.

Primary outcomes:
measure: inhibition of platelet aggregation
timeFrame: at 30 days follow-up
measure: inhibition of platelet aggregation
timeFrame: at 1st hour after administration of the repeated loading dose of clopidogrel / placebo
measure: inhibition of platelet aggregation
timeFrame: at 2nd hour after administration of the repeated loading dose of clopidogrel / placebo
measure: inhibition of platelet aggregation
timeFrame: at 6th hour after administration of the repeated loading dose of clopidogrel / placebo
measure: inhibition of platelet aggregation
timeFrame: at 24th hour after administration of the repeated loading dose of clopidogrel / placebo
Secondary outcomes:
measure: Secondary outcome
timeFrame: 30 days
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Krakowskie Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii Carint Scanmed Sp. z o.o
Study officials:
affiliation: Krakowskie Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii Carint Scanmed Sp. z o.o
name: Roman Wojdyła, MD
role: PRINCIPAL_INVESTIGATOR
References: