Back to resultsEffect 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)
Primary Purpose
Acute Myocardial Infarction
Status
Withdrawn
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Clopidogrel
Clopidogrel
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring STEMI, NSTEMI, clopidogrel, Areplex, REL-0609
Eligibility 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.
Sites / Locations
- Krakowskie Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii Carint Scanmed Sp. z o.o
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Clopidogrel - Repeated Loading Dose
Clopidogrel - standard of care
Arm Description
repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy for 30 days (150 mg/day)
no repeated loading dose of clopidogrel with clopidogrel continuous therapy for 30 days (75 mg/day)
Outcomes
Primary Outcome Measures
inhibition of platelet aggregation
inhibition of platelet aggregation at the 30-day follow-up visit.
inhibition of platelet aggregation
inhibition of platelet aggregation 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
inhibition of platelet aggregation
inhibition of platelet aggregation 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
Secondary Outcome Measures
Secondary outcome
frequency of bleeding complications within 30 days
Full Information
NCT ID
NCT01636180
First Posted
April 5, 2012
Last Updated
March 5, 2015
Sponsor
Fundacja Ośrodek Badań Medycznych
Collaborators
KCRI
1. Study Identification
Unique Protocol Identification Number
NCT01636180
Brief 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.
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Withdrawn
Study Start Date
March 2012 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacja Ośrodek Badań Medycznych
Collaborators
KCRI
4. Oversight
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
STEMI, NSTEMI, clopidogrel, Areplex, REL-0609
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clopidogrel - Repeated Loading Dose
Arm Type
Experimental
Arm Description
repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy for 30 days (150 mg/day)
Arm Title
Clopidogrel - standard of care
Arm Type
Active Comparator
Arm Description
no repeated loading dose of clopidogrel with clopidogrel continuous therapy for 30 days (75 mg/day)
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy for 30 days (150 mg/day)
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
no repeated loading dose of clopidogrel with clopidogrel continuous therapy for 30 days (75 mg/day)
Primary Outcome Measure Information:
Title
inhibition of platelet aggregation
Description
inhibition of platelet aggregation at the 30-day follow-up visit.
Time Frame
at 30 days follow-up
Title
inhibition of platelet aggregation
Description
inhibition of platelet aggregation at 1st hour after administration of the repeated loading dose of clopidogrel / placebo
Time Frame
at 1st hour after administration of the repeated loading dose of clopidogrel / placebo
Title
inhibition of platelet aggregation
Description
inhibition of platelet aggregation at 2nd hour after administration of the repeated loading dose of clopidogrel / placebo
Time Frame
at 2nd hour after administration of the repeated loading dose of clopidogrel / placebo
Title
inhibition of platelet aggregation
Description
inhibition of platelet aggregation at 6th hour after administration of the repeated loading dose of clopidogrel / placebo
Time Frame
at 6th hour after administration of the repeated loading dose of clopidogrel / placebo
Title
inhibition of platelet aggregation
Description
inhibition of platelet aggregation at 24th hour after administration of the repeated loading dose of clopidogrel / placebo
Time Frame
at 24th hour after administration of the repeated loading dose of clopidogrel / placebo
Secondary Outcome Measure Information:
Title
Secondary outcome
Description
frequency of bleeding complications within 30 days
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roman Wojdyła, MD
Organizational Affiliation
Krakowskie Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii Carint Scanmed Sp. z o.o
Official's Role
Principal Investigator
Facility Information:
Facility Name
Krakowskie Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii Carint Scanmed Sp. z o.o
City
Krakow
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
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.
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