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Clopidogrel Versus Adenosin in Non Urgent Percutaneous Coronary Intervention (PCI) (RACE)

Primary Purpose

Stable Angina, Percutaneous Coronary Intervention

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Adenosin
placebo
Clopidogrel
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stable Angina focused on measuring Stable angina, Percutaneous Coronary Intervention, Myonecrosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Occlusion resulting in Thrombolysis In Myocardial Infarction (TIMI) grade 0 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 50 b.p.m.
  • Allergy to adenosine
  • The occurrence of myo-cardial infarction within one week

Sites / Locations

  • Policlinico Umberto IRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

III

A

placebo

Arm Description

Outcomes

Primary Outcome Measures

20%

Secondary Outcome Measures

0%

Full Information

First Posted
September 11, 2008
Last Updated
May 5, 2009
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT00751491
Brief Title
Clopidogrel Versus Adenosin in Non Urgent Percutaneous Coronary Intervention (PCI)
Acronym
RACE
Official Title
Randomized Comparison of Adenosin Intracoronary Infusion and Clopidogrel Pretreatment on Myonecrosis Occurence in Elective PCI
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2009 (Anticipated)
Study Completion Date
September 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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 greater than 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. The investigators 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, the investigators 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Angina, Percutaneous Coronary Intervention
Keywords
Stable angina, Percutaneous Coronary Intervention, Myonecrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
III
Arm Type
Active Comparator
Arm Title
A
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Adenosin
Other Intervention Name(s)
PERCUTANEOUS CORONARY ANGIOGRAPHY
Intervention Description
Intracoronary Adenosin 50 microg;
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
no intervention
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
Clopidogrel 300/600 mg
Primary Outcome Measure Information:
Title
20%
Time Frame
12 months
Secondary Outcome Measure Information:
Title
0%
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Baseline creatine-kinase (CK) and creatine-kinase-myocardial band (CK-MB) had to be within normal limits (a normal CK and CK-MB and elevated troponin allowed inclusion) Exclusion Criteria: Occlusion resulting in Thrombolysis In Myocardial Infarction (TIMI) grade 0 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 50 b.p.m. Allergy to adenosine The occurrence of myo-cardial infarction within one week
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GENNARO SARDELLA, MD
Organizational Affiliation
DEPT.CARDIOLOGY-POLICLINICO UMBERTO I-SAPIENZA UNIVERSITY OF ROME
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
MASSIMO MANCONE, MD
Organizational Affiliation
DEPT.CARDIOLOGY-POLICLINICO UMBERTO I-SAPIENZA UNIVERSITY OF ROME
Official's Role
Study Director
Facility Information:
Facility Name
Policlinico Umberto I
City
Rome
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GENNARO SARDELLA, MD
Phone
+390649979035
Email
rino.sardella@uniroma1.it
First Name & Middle Initial & Last Name & Degree
GENNARO SARDELLA, MD

12. IPD Sharing Statement

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Clopidogrel Versus Adenosin in Non Urgent Percutaneous Coronary Intervention (PCI)

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