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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University Hospital Ostrava
Sponsor:
Information provided by:
University Hospital Ostrava
ClinicalTrials.gov Identifier:
NCT01381185
First received: June 22, 2011
Last updated: August 7, 2014
Last verified: August 2014

June 22, 2011
August 7, 2014
May 2011
December 2014   (final data collection date for primary outcome measure)
Platelet inhibition level [ Time Frame: 5 days ] [ Designated as safety issue: No ]
The main outcome measure is the difference in platelet inhibition between clopidogrel 1x75mg and 2x75mg in HPR patients
Stent Thrombosis [ Time Frame: 30 days ] [ Designated as safety issue: No ]
The main outcome measure are in general ischemic vascular events (myocardial infarction, re-infarction, need of cardiac by-pass surgery)
Complete list of historical versions of study NCT01381185 on ClinicalTrials.gov Archive Site
  • Bleeding Events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    TIMI major/minor bleeding Bleeding prediction with Crusade bleeding score (calculator free accessible at http://www.crusadebleedingscore.org/index.html)
  • Stent thrombosis [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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--
Bleeding Events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
TIMI major/minor bleeding Bleeding prediction with Crusade bleeding score (calculator free accessible at http://www.crusadebleedingscore.org/index.html)
Ischaemic events (not IST) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
unplanned targed vessel revascularisation (TVR), need for coronary - aortic by-pass graft ,myocardial infarction
Not Provided
 
REsistance to Aspirin and Clopidogrel in acuTe Myocardial Infarction
Phase IV Study of Aspirin and Clopidogrel Therapy Tailored by Functional Thrombocyte Examination (PFA-100, LTA and VerifyNOW) in Acute Myocardial Infarction

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Acute Myocardial Infarction
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
  • 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
    Intervention: Drug: Aspirin 200mg qd, Clopidogrel 2x75mg qd

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
154
January 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
21 Years to 90 Years
No
Contact: Vaclav Prochazka, MD, PhD, MSc +420597372510 vaclav.prochazka@fno.cz
Czech Republic
 
NCT01381185
FNO-KVO-1, plasek680
Yes
Jiri Plasek, MD, University Hospital Ostrava
University Hospital Ostrava
Not Provided
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
University Hospital Ostrava
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP