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Adenosin Intracoronary Infusion in Non Urgent Percutaneous Coronary Intervention(PCI) (REACT)
This study is ongoing, but not recruiting participants.
Sponsored by: University of Roma La Sapienza
Information provided by: University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT00751491
  Purpose

Percutaneous coronary intervention(PCI)is associated with up to 30%incidence of myonecrosis,as reflected by elevation of cardiac enzymes in a successful procedure. Apart from side-branch occlusion,intimal dissection and coronary spasm,a possible aetiology of myonecrosis after PCI might be distal embolization of atherogenic materials from plaque disruption causing obstruction of blood flow at capillary level resulting in micro-infarction.Recent studies have suggested that pretreatment with adenosine in the cath lab and Clopidogrel and statins > 6 hours before may be associated with a reduction in infarct size after reperfusion therapy for acute myocardial infarction.Whether pretreatment with adenosine decreases the incidence of myonecrosis in patients undergoing non urgent PCI is not fully known. We propose that adenosine-induced hyperaemia can potentially ameliorate the deleterious effects of distal embolization associated with non-urgent PCI through dilatation of the microvasculature.Mechanistically,this may reduce capillary obstruction by facilitating the throughput passage of embolized platelet thrombi out to the venous end of the coronary circulation,thereby reducing the incidence of post-PCI myonecrosis.In this prospective,randomized,open-label study,we evaluated the incidence of myonecrosis after non-urgent PCI with a treatment with intracoronary adenosine compared with pretreatment of loading dose of Clopidogrel 300/600 mg >/< 6 hours.


Condition Intervention Phase
Stable Angina
Percutaneous Coronary Intervention
Drug: Adenosin,Clopidogrel
Phase III

MedlinePlus related topics: Angina
Drug Information available for: Clopidogrel Clopidogrel Bisulfate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Randomized Evaluation of Adenosin Intracoronary Infusion Versus Clopidogrel Pretreatment on Myonecrosis Occurence in Elective PCI

Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • 20% [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 0% [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: September 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
III: Active Comparator Drug: Adenosin,Clopidogrel
Intracoronary Adenosin 50microg Clopidogrel 300/600mg
A: Active Comparator Drug: Adenosin,Clopidogrel
Intracoronary Adenosin 50microg Clopidogrel 300/600mg

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Baseline creatine-kinase(CK)and creatine-kinase-myocardial band(CK-MB)had to be within normal limits(anormalCKandCK-MB and elevated troponin allowed inclusion).

Exclusion Criteria:

  • Occlusion resulting in Thrombolysis In MyocardialInfarction(TIMI)grade0 antegrade flow
  • Thrombus-laden lesions
  • Significant left main coronary stenosis
  • Left ventricular ejection fraction 30%
  • Inability to give informed consent
  • Bradycardia with heart rate below 50b.p.m.
  • Allergy to adenosine
  • The occurrence of myo-cardial infarction within one week
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: POLICLINICO UMBERTO I-SAPIENZA UNIVERSITY OF ROME ( GENNARO SARDELLA )
Study ID Numbers: SARD55
Study First Received: September 11, 2008
Last Updated: September 11, 2008
ClinicalTrials.gov Identifier: NCT00751491  
Health Authority: Italy: Ethics Committee

Keywords provided by University of Roma La Sapienza:
Stable angina
Percutaneous Coronary Intervention
Myonecrosis

Study placed in the following topic categories:
Clopidogrel
Angina Pectoris

Additional relevant MeSH terms:
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009