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)

• ClinicalTrials.gov Identifier: NCT01636180
• Recruitment Status: Withdrawn
• First Posted: July 10, 2012
• Last Update Posted: March 6, 2015
• Sponsor: Fundacja Ośrodek Badań Medycznych
• Collaborator: KCRI
• Information provided by (Responsible Party): Fundacja Ośrodek Badań Medycznych

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acute Myocardial Infarction	Drug: Clopidogrel	Phase 4

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• 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.
• Study Start Date: March 2012
• Estimated Primary Completion Date: May 2015

Arms and Interventions

Arm	Intervention/treatment
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)

Outcome Measures

Primary Outcome Measures :

1. inhibition of platelet aggregation [ Time Frame: at 30 days follow-up ]
   inhibition of platelet aggregation at the 30-day follow-up visit.
2. 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
3. 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
4. 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
5. 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 :

1. Secondary outcome [ Time Frame: 30 days ]
   frequency of bleeding complications within 30 days

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: 1.0, 2009-06-06
• 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:

Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Clopidogrel; 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