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. - Full Text View

Purpose

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.

Condition	Intervention	Phase
Acute Myocardial Infarction	Drug: Clopidogrel	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: 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.

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

Drug Information available for: Clopidogrel bisulfate

U.S. FDA Resources

Further study details as provided by Fundacja Ośrodek Badań Medycznych:

Primary Outcome Measures:

inhibition of platelet aggregation [ Time Frame: at 30 days follow-up ] [ Designated as safety issue: No ]
inhibition of platelet aggregation at the 30-day follow-up visit.
inhibition of platelet aggregation [ Time Frame: at 1st hour after administration of the repeated loading dose of clopidogrel / placebo ] [ Designated as safety issue: No ]
inhibition of platelet aggregation at 1st hour after administration of the repeated loading dose of clopidogrel / placebo
inhibition of platelet aggregation [ Time Frame: at 2nd hour after administration of the repeated loading dose of clopidogrel / placebo ] [ Designated as safety issue: No ]
inhibition of platelet aggregation at 2nd hour after administration of the repeated loading dose of clopidogrel / placebo
inhibition of platelet aggregation [ Time Frame: at 6th hour after administration of the repeated loading dose of clopidogrel / placebo ] [ Designated as safety issue: No ]
inhibition of platelet aggregation at 6th hour after administration of the repeated loading dose of clopidogrel / placebo
inhibition of platelet aggregation [ Time Frame: at 24th hour after administration of the repeated loading dose of clopidogrel / placebo ] [ Designated as safety issue: No ]
inhibition of platelet aggregation at 24th hour after administration of the repeated loading dose of clopidogrel / placebo

Secondary Outcome Measures:

Secondary outcome [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
frequency of bleeding complications within 30 days

Estimated Enrollment:	60
Study Start Date:	March 2012
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Clopidogrel - Repeated Loading Dose repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy for 30 days (150 mg/day)	Drug: Clopidogrel repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy for 30 days (150 mg/day)
Active Comparator: Clopidogrel - standard of care no repeated loading dose of clopidogrel with clopidogrel continuous therapy for 30 days (75 mg/day)	Drug: Clopidogrel no repeated loading dose of clopidogrel with clopidogrel continuous therapy for 30 days (75 mg/day)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01636180

Locations

Poland
Krakowskie Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii Carint Scanmed Sp. z o.o
Krakow, Poland

Sponsors and Collaborators

Fundacja Ośrodek Badań Medycznych

Krakow Cardiovascular Research Institute

Investigators

Principal Investigator:

Roman Wojdyła, MD

Krakowskie Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii Carint Scanmed Sp. z o.o

More Information

No publications provided

Responsible Party:	Fundacja Ośrodek Badań Medycznych
ClinicalTrials.gov Identifier:	NCT01636180 History of Changes
Other Study ID Numbers:	1.0, 2009-06-06
Study First Received:	April 5, 2012
Last Updated:	July 5, 2012
Health Authority:	Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Poland: Ethics Committee

Keywords provided by Fundacja Ośrodek Badań Medycznych:

STEMI
NSTEMI
clopidogrel
Areplex
REL-0609

Additional relevant MeSH terms:

Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Hematologic Agents

Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013

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. (REL-0609)