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REsistance to Aspirin and Clopidogrel in acuTe Myocardial Infarction (REACT-MI)

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. Identifier: NCT01381185
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : October 27, 2016
Information provided by (Responsible Party):
University Hospital Ostrava

Brief Summary:
The purpose of this study is to compare 3 point-of-care methods for monitoring antiplatelet therapy to golden standard (Light transmittance aggregometry-LTA) in high risk population of acute myocardial infarction patients. If two methods (PFA-100, VerifyNOW,Multiplate or LTA) will indicate insufficient antiplatelet blockade/high residual reactivity for aspirin, clopidogrel or both, the dose of aspirin will be increased to 200mg qd and the dose of clopidogrel will be increased to 2x75mg qd.In addition genotyping of CYP2C19 (6 alleles) will be performed.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: Aspirin 200mg qd, Clopidogrel 2x75mg qd Phase 4

Detailed Description:
Dual antiplatelet therapy is the cornerstone of treatment of coronary heart disease after coronary stent implantation. The interindividual response to this therapy is not uniform, however. There are subgroups of patients, where no anticipated antiplatelet effect to either aspirin, clopidogrel or both is reached. The term of aspirin/clopidogrel resistance has been introduced few years ago, most recently it was substituted by more suitable term - high on-treatment residual platelet reactivity (HPR). Although there are many assays to monitor antiplatelet therapy, uncertainty still remains about the correlation of HPR with ischemic vascular events (in-stent thrombosis, myocardial infarction, etc.). Thus platelet aggregation testing is considered to be the most promising method to indicate inappropriate/low response to aspirin/clopidogrel, however the best suited method is not established yet. Up-to date light transmittance aggregometry is widely accepted as golden standard, nonetheless labour intensive and difficult to standardize. On the other hand many point-of-care aggregation testing methods like PFA-100, VerifyNOW, Multiplate etc. have been introduced, their role in clinical practice is uncertain, however. The biggest challenge of today is to determine platelet function assay, which could reliably indicate future ischemic vascular events;moreover it could be potentially used to tailor antiplatelet therapy and precede these events. It was demonstrated, that gene polymorphism - CYP2C19*2 and CYP2C9*3 loss of function is conjugated with an increased occurrence of stent thrombosis. Within the project we also plan to examine 4 alleles which have not been examined in detail before.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase IV Study of Aspirin and Clopidogrel Therapy Tailored by Functional Thrombocyte Examination (PFA-100, LTA and VerifyNOW) in Acute Myocardial Infarction
Study Start Date : May 2011
Actual Primary Completion Date : June 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
No Intervention: Standard therapy
standard dose of 100mg aspirin qd and 1x75mg Clopidogrel will be given
Active Comparator: ASA/CLP increase
According to 2 platelet monitoring assays HPR confirmation aspirin will be increased to 200mg qd, clopidogrel to 2x75mg qd
Drug: Aspirin 200mg qd, Clopidogrel 2x75mg qd
According to 2 platelet monitoring assays HPR confirmation aspirin will be increased to 200mg qd, clopidogrel to 2x75mg qd. This treatment will be given for 30 days from index event (myocardial infarction)
Other Name: R-130964

Primary Outcome Measures :
  1. Platelet inhibition level [ Time Frame: 5 days ]
    The main outcome measure is the difference in platelet inhibition between clopidogrel 1x75mg and 2x75mg in HPR patients

Secondary Outcome Measures :
  1. Bleeding Events [ Time Frame: 30 days ]
    TIMI major/minor bleeding Bleeding prediction with Crusade bleeding score (calculator free accessible at

  2. Stent thrombosis [ Time Frame: 30 days ]
    In-stent thrombosis will be assessed in 30-days time-frame in all patients included in the trial. -- due to inadequate power of the trial IST cannot be primary outcome measure--

Other Outcome Measures:
  1. Ischaemic events (not IST) [ Time Frame: 30 days ]
    unplanned targed vessel revascularisation (TVR), need for coronary - aortic by-pass graft ,myocardial infarction

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • acute myocardial infarction (verified by troponin I elevation and ST-segment deviation ≥0.1mV in ≥2 contiguous ECG leads persisting for at least 20 minutes and angiographical proof of coronary stenosis )
  • preceding antiplatelet medication with aspirin100mg qd/5 and more days before PCI
  • pre-treatment with 600mg Clopidogrel loading dose
  • preferably patients with drug eluting stent implantation
  • signed informed consent

Exclusion Criteria:

  • stable/unstable angina pectoris
  • active malignancy
  • contraindication to antiplatelet therapy
  • increased risk of bleeding (trauma, surgery or non-ischemic stroke in last month)
  • effective anticoagulation therapy:LMWH, Pradaxa, Xarelto, Warfarin
  • known thrombophile disorder
  • SIRS
  • renal insufficiency (eGFR under 15ml/min)
  • severe anemia (<80 g/l)
  • polyglobulia (>160 g/l)
  • pregnancy
  • Hematocrit <0.25 > 0.55

Information from the National Library of Medicine

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 identifier (NCT number): NCT01381185

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Czech Republic
University Hospital Ostrava
Ostrava, Poruba, Czech Republic, 70852
Departement of Laboratory Medicine, Prostejov Hospital
Prostejov, Czech Republic, 79604
Sponsors and Collaborators
University Hospital Ostrava
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Principal Investigator: Jiri Plasek, MD, PhD Department of Cardiology, University Hospital Ostrava
Study Chair: Miroslav Homza, MD Department of Cardiology, University Hospital Ostrava
Study Chair: Jaromir Gumulec, MD Institute of clinical Hematology, University Hospital Ostrava
Additional Information:
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Responsible Party: University Hospital Ostrava Identifier: NCT01381185    
Other Study ID Numbers: FNO-KVO-1
plasek680 ( Other Identifier: University Hospital Ostrava )
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Keywords provided by University Hospital Ostrava:
myocardial infarction
percutaneous coronary intervention (PCI)
high platelet reactivity (HPR)
Additional relevant MeSH terms:
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Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents