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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)

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01636180
First Posted: July 10, 2012
Last Update Posted: March 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
KCRI
Information provided by (Responsible Party):
Fundacja Ośrodek Badań Medycznych
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    frequency of bleeding complications within 30 days


Enrollment: 0
Study Start Date: March 2012
Estimated Primary Completion Date: May 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
KCRI
Investigators
Principal Investigator: Roman Wojdyła, MD Krakowskie Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii Carint Scanmed Sp. z o.o
  More Information

Responsible Party: Fundacja Ośrodek Badań Medycznych
ClinicalTrials.gov Identifier: NCT01636180     History of Changes
Other Study ID Numbers: 1.0, 2009-06-06
First Submitted: April 5, 2012
First Posted: July 10, 2012
Last Update Posted: March 6, 2015
Last Verified: March 2015

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
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
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors