Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| III | Active Comparator |
| |
| A | Active Comparator |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adenosin | Drug | Intracoronary Adenosin 50 microg; |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 20% | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 0% | 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico Umberto I | Recruiting | Rome | 00161 | Italy |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 3, 2009 | |
| Reset | Dec 4, 2009 | |
| Release | Dec 9, 2009 | |
| Reset | Jan 12, 2010 | |
| Release | Jan 13, 2010 | |
| Reset | Feb 4, 2010 | |
| Release | Oct 25, 2010 | |
| Reset | Nov 24, 2010 | |
| Release | Jan 3, 2013 | |
| Reset | Feb 5, 2013 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 3, 2009 | Dec 4, 2009 | |||
| Dec 9, 2009 |
| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Other | no intervention |
|
| Clopidogrel | Drug | Clopidogrel 300/600 mg |
|
| Jan 12, 2010 |
| Jan 13, 2010 | Feb 4, 2010 |
| Oct 25, 2010 | Nov 24, 2010 |
| Jan 3, 2013 | Feb 5, 2013 |
| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |