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)
![]() |
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. |
ClinicalTrials.gov Identifier: NCT01636180 |
Recruitment Status :
Withdrawn
First Posted : July 10, 2012
Last Update Posted : March 6, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Myocardial Infarction | Drug: Clopidogrel | Phase 4 |
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 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 |

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) |
- 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 [ Time Frame: 30 days ]frequency of bleeding complications within 30 days

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Poland | |
Krakowskie Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii Carint Scanmed Sp. z o.o | |
Krakow, Poland |
Principal Investigator: | Roman Wojdyła, MD | Krakowskie Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii Carint Scanmed Sp. z o.o |
Responsible Party: | Fundacja Ośrodek Badań Medycznych |
ClinicalTrials.gov Identifier: | NCT01636180 |
Other Study ID Numbers: |
1.0, 2009-06-06 |
First Posted: | July 10, 2012 Key Record Dates |
Last Update Posted: | March 6, 2015 |
Last Verified: | March 2015 |
STEMI NSTEMI clopidogrel Areplex REL-0609 |
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 |