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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Fundacja Ośrodek Badań Medycznych.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Krakow Cardiovascular Research Institute
Information provided by (Responsible Party):
Fundacja Ośrodek Badań Medycznych
ClinicalTrials.gov Identifier:
NCT01636180
First received: April 5, 2012
Last updated: July 5, 2012
Last verified: July 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014