Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE June 22, 2011
First Posted Date  ICMJE June 27, 2011
Last Update Posted Date October 27, 2016
Study Start Date  ICMJE May 2011
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2014)
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
Original Primary Outcome Measures  ICMJE
 (submitted: June 22, 2011)
Stent Thrombosis [ Time Frame: 30 days ]
The main outcome measure are in general ischemic vascular events (myocardial infarction, re-infarction, need of cardiac by-pass surgery)
Change History Complete list of historical versions of study NCT01381185 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2014)
  • Bleeding Events [ Time Frame: 30 days ]
    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 ]
    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--
Original Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2011)
Bleeding Events [ Time Frame: 30 days ]
TIMI major/minor bleeding Bleeding prediction with Crusade bleeding score (calculator free accessible at http://www.crusadebleedingscore.org/index.html)
Current Other Pre-specified Outcome Measures
 (submitted: August 3, 2014)
Ischaemic events (not IST) [ Time Frame: 30 days ]
unplanned targed vessel revascularisation (TVR), need for coronary - aortic by-pass graft ,myocardial infarction
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE REsistance to Aspirin and Clopidogrel in acuTe Myocardial Infarction
Official Title  ICMJE Phase IV Study of Aspirin and Clopidogrel Therapy Tailored by Functional Thrombocyte Examination (PFA-100, LTA and VerifyNOW) in Acute Myocardial Infarction
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Acute Myocardial Infarction
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2014)
154
Original Estimated Enrollment  ICMJE
 (submitted: June 22, 2011)
120
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01381185
Other Study ID Numbers  ICMJE FNO-KVO-1
plasek680 ( Other Identifier: University Hospital Ostrava )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital Ostrava
Study Sponsor  ICMJE University Hospital Ostrava
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University Hospital Ostrava
Verification Date October 2016

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