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.
NCT01636180 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL
Last updated 2015-03-06
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.
Conditions
- Acute Myocardial Infarction
Interventions
- DRUG
-
Clopidogrel
repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy for 30 days (150 mg/day)
- DRUG
-
Clopidogrel
no repeated loading dose of clopidogrel with clopidogrel continuous therapy for 30 days (75 mg/day)
Sponsors & Collaborators
-
KCRI
collaborator OTHER -
Fundacja Ośrodek Badań Medycznych
lead OTHER
Principal Investigators
-
Roman Wojdyła, MD · Krakowskie Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii Carint Scanmed Sp. z o.o
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-03-31
- Primary Completion
- 2015-05-31
Countries
- Poland
Study Locations
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