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NCT01636180 | Withdrawn Phase 4

• 1 other identifier: 1.0, 2009-06-06
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myocardial Infarction

Keywords

STEMI; NSTEMI; clopidogrel; Areplex; REL-0609

Outcome Measures

Primary Outcomes (5)

• inhibition of platelet aggregation

  inhibition of platelet aggregation at the 30-day follow-up visit.

  at 30 days follow-up

• inhibition of platelet aggregation

  inhibition of platelet aggregation at 1st hour after administration of the repeated loading dose of clopidogrel / placebo

  at 1st hour after administration of the repeated loading dose of clopidogrel / placebo

• inhibition of platelet aggregation

  inhibition of platelet aggregation at 2nd hour after administration of the repeated loading dose of clopidogrel / placebo

  at 2nd hour after administration of the repeated loading dose of clopidogrel / placebo

• inhibition of platelet aggregation

  inhibition of platelet aggregation at 6th hour after administration of the repeated loading dose of clopidogrel / placebo

  at 6th hour after administration of the repeated loading dose of clopidogrel / placebo

• inhibition of platelet aggregation

  inhibition of platelet aggregation at 24th hour after administration of the repeated loading dose of clopidogrel / placebo

  at 24th hour after administration of the repeated loading dose of clopidogrel / placebo

Secondary Outcomes (1)

• Secondary outcome

  30 days

Study Arms (2)

Clopidogrel - Repeated Loading Dose

EXPERIMENTAL

repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy for 30 days (150 mg/day)

Drug: Clopidogrel

Clopidogrel - standard of care

ACTIVE COMPARATOR

no repeated loading dose of clopidogrel with clopidogrel continuous therapy for 30 days (75 mg/day)

Drug: Clopidogrel

Interventions

Clopidogrel DRUG

repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy for 30 days (150 mg/day)

Clopidogrel - Repeated Loading Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacja Ośrodek Badań Medycznych: lead
• KCRI: collaborator

Study Sites (1)

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

Krakow, Poland

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Roman Wojdyła, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2012
• First Posted: July 10, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2015
• Last Updated: March 6, 2015

Record last verified: 2015-03

Locations

PL (1)