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.

Acute Myocardial Infarction Clinical Trial

— REL-0609  

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01636180
• Other study ID #: 1.0, 2009-06-06
• Status: Withdrawn
• Phase: Phase 4
• First received: April 5, 2012
• Last updated: March 5, 2015
• Start date: March 2012

Study information

• Verified date: March 2015
• Source: Fundacja Osrodek Badan Medycznych
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPoland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Clopidogrel
repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy for 30 days (150 mg/day)
• Clopidogrel
no repeated loading dose of clopidogrel with clopidogrel continuous therapy for 30 days (75 mg/day)

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Fundacja Osrodek Badan Medycznych	KCRI

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inhibition of platelet aggregation	inhibition of platelet aggregation at the 30-day follow-up visit.	at 30 days follow-up	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Secondary outcome	frequency of bleeding complications within 30 days	30 days	Yes