REsistance to Aspirin and Clopidogrel in acuTe Myocardial Infarction
REACT-MI
Phase IV Study of Aspirin and Clopidogrel Therapy Tailored by Functional Thrombocyte Examination (PFA-100, LTA and VerifyNOW) in Acute Myocardial Infarction
2 other identifiers
interventional
154
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2011
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 22, 2011
CompletedFirst Posted
Study publicly available on registry
June 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedOctober 27, 2016
October 1, 2016
4.1 years
June 22, 2011
October 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Platelet inhibition level
The main outcome measure is the difference in platelet inhibition between clopidogrel 1x75mg and 2x75mg in HPR patients
5 days
Secondary Outcomes (2)
Bleeding Events
30 days
Stent thrombosis
30 days
Other Outcomes (1)
Ischaemic events (not IST)
30 days
Study Arms (2)
Standard therapy
NO INTERVENTIONstandard dose of 100mg aspirin qd and 1x75mg Clopidogrel will be given
ASA/CLP increase
ACTIVE COMPARATORAccording to 2 platelet monitoring assays HPR confirmation aspirin will be increased to 200mg qd, clopidogrel to 2x75mg qd
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University Hospital Ostrava
Ostrava, Poruba, 70852, Czechia
Departement of Laboratory Medicine, Prostejov Hospital
Prostějov, 79604, Czechia
Related Publications (3)
Marcucci R, Gori AM, Paniccia R, Giusti B, Valente S, Giglioli C, Buonamici P, Antoniucci D, Abbate R, Gensini GF. Cardiovascular death and nonfatal myocardial infarction in acute coronary syndrome patients receiving coronary stenting are predicted by residual platelet reactivity to ADP detected by a point-of-care assay: a 12-month follow-up. Circulation. 2009 Jan 20;119(2):237-42. doi: 10.1161/CIRCULATIONAHA.108.812636. Epub 2008 Dec 31.
PMID: 19118249BACKGROUNDCuisset T, Cayla G, Frere C, Quilici J, Poyet R, Gaborit B, Bali L, Morange PE, Alessi MC, Bonnet JL. Predictive value of post-treatment platelet reactivity for occurrence of post-discharge bleeding after non-ST elevation acute coronary syndrome. Shifting from antiplatelet resistance to bleeding risk assessment? EuroIntervention. 2009 Aug;5(3):325-9. doi: 10.4244/51.
PMID: 19736156BACKGROUNDSibbing D, Byrne RA, Bernlochner I, Kastrati A. High platelet reactivity and clinical outcome - fact and fiction. Thromb Haemost. 2011 Aug;106(2):191-202. doi: 10.1160/TH11-01-0040. Epub 2011 Apr 20.
PMID: 21505714BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2011
First Posted
June 27, 2011
Study Start
May 1, 2011
Primary Completion
June 1, 2015
Study Completion
July 1, 2015
Last Updated
October 27, 2016
Record last verified: 2016-10