NCT00751491

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

May 6, 2009

Status Verified

May 1, 2009

Enrollment Period

1 year

First QC Date

September 11, 2008

Last Update Submit

May 5, 2009

Conditions

Stable AnginaPercutaneous Coronary Intervention

Keywords

Stable anginaPercutaneous Coronary InterventionMyonecrosis

Outcome Measures

Primary Outcomes (1)

  • 20%

    12 months

Secondary Outcomes (1)

  • 0%

    12 months

Study Arms (3)

III

ACTIVE COMPARATOR
Drug: Clopidogrel

A

ACTIVE COMPARATOR
Drug: Adenosin

placebo

PLACEBO COMPARATOR
Other: placebo

Interventions

AdenosinDRUG

Intracoronary Adenosin 50 microg;

Also known as: PERCUTANEOUS CORONARY ANGIOGRAPHY
A
placeboOTHER

no intervention

placebo
ClopidogrelDRUG

Clopidogrel 300/600 mg

III

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico Umberto I

Rome, 00161, Italy

RECRUITING

MeSH Terms

Conditions

Angina, Stable

Interventions

AdenosineClopidogrel

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Purine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesTiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • GENNARO SARDELLA, MD

    DEPT.CARDIOLOGY-POLICLINICO UMBERTO I-SAPIENZA UNIVERSITY OF ROME

    PRINCIPAL INVESTIGATOR

  • MASSIMO MANCONE, MD

    DEPT.CARDIOLOGY-POLICLINICO UMBERTO I-SAPIENZA UNIVERSITY OF ROME

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2008

First Posted

September 12, 2008

Study Start

September 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

May 6, 2009

Record last verified: 2009-05

Locations

IT(1)