Coronary AngioplastyPhase 3PREVENT-ICARUSNCT01148147
Intracoronary Adenosine Administration to Prevent Periprocedural Myonecrosis in Elective Coronary Angioplasty
A Phase 3 study testing Adenosine in people with Coronary Angioplasty, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
Trial summary
Aim of the study is to evaluate the benefits from adjunctive intracoronary administration of adenosin in elective patients undergoing coronary angioplasty. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Angioplasty
- What is being tested?
- Adenosine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2009to Aug 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing elective coronary angioplasty
Who cannot join
- Marked Bradycardia (< 40 bpm)
- Previous allergy to adenosine
- Inability to sign the informed consent
- Asthma
- Elevated cardiac enzymes (troponin I o CK-MB)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Cardiac and Vascular Periprocedural Complications in Patients Undergoing Coronary Angiography or Angioplasty: Intracoronary Adenosine Administration to Prevent Periprocedural Myonecrosis in Elective Coronary Angioplasty. A Prospective Double-blind Randomized Trial.
Aim of the study is to evaluate the benefits from adjunctive intracoronary administration of adenosin in elective patients undergoing coronary angioplasty.
Read the detailed description
This study will investigate the effects of adjunctive intracoronary administration of adenosine on periprocedural myocardial infarction as compared to placebo.
This is a double-blind randomized trial single-center study. The enrollment will last 10 months.
- Conditions
- Coronary Angioplasty
- Being tested
- Adenosine, Placebo
- Keywords
- Adenosine, randomized trial, periprocedural myocardial necrosis, elective coronary angioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdenosineDrug
Intracoronary adenosine administration (180 ug for LCA and 120 ug for RCA)
PlaceboDrug
Intracoronary Placebo administration
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Intracoronary Placebo administration Receives: Drug: Placebo |
| Adenosine | Active comparator | Intracoronary adenosine administration Receives: Drug: Adenosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in troponin I (> 3 times the upper normal limit)
Measured: At 12 hours after the procedure
Secondary outcomes (2)
MACE(death, MI, urgent target-vessel revascularization)
Measured: 72 hours
Angiographic Coronary flow, as evaluated by corrected TIMI frame count.
Measured: 1 minute after the final stent implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startNov 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary AngioplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Sponsor type
- University, hospital or other
- Investigators
- Giuseppe De Luca, MD, Principal investigator, AOU Maggiore della Carità
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148147
- Sponsor's protocol ID
- CE 93/09
- Other IDs
- 2009-013681-92, 2009
- Acronym
- PREVENT-ICARUS
- Status last verified
- Sep 2010
- First submitted
- 7 Jun 2010
- Last updated
- 8 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
De Luca G, Iorio S, Venegoni L, Marino P. Evaluation of intracoronary adenosine to prevent periprocedural myonecrosis in elective percutaneous coronary intervention (from the PREVENT-ICARUS Trial). Am J Cardiol. 2012 Jan 15;109(2):202-7. doi: 10.1016/j.amjcard.2011.08.027. Epub 2011 Oct 14.
PubMed 22000773
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Cardiac and Vascular Periprocedural Complications in Patients Undergoing Coronary Angiography or Angioplasty: Intracoronary Adenosine Administration to Prevent Periprocedural Myonecrosis in Elective Coronary Angioplasty. A Prospective Double-blind Randomized Trial.
- ClinicalTrials.gov ID
- NCT01148147
- Acronym / sponsor ID
- PREVENT-ICARUS / CE 93/09
- Conditions
- Coronary Angioplasty
- Keywords
- Adenosine, randomized trial, periprocedural myocardial necrosis, elective coronary angioplasty
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della CaritaUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the study is to evaluate the benefits from adjunctive intracoronary administration of adenosin in elective patients undergoing coronary angioplasty.
Detailed description
This study will investigate the effects of adjunctive intracoronary administration of adenosine on periprocedural myocardial infarction as compared to placebo.
This is a double-blind randomized trial single-center study. The enrollment will last 10 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboIntracoronary Placebo administration |
| Adenosine | Active comparator | Drug: AdenosineIntracoronary adenosine administration |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elective coronary angioplasty
Key exclusion criteria (5 listed)
- Marked Bradycardia (< 40 bpm)
- Previous allergy to adenosine
- Inability to sign the informed consent
- Asthma
- Elevated cardiac enzymes (troponin I o CK-MB)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdenosineIntracoronary adenosine administration (180 ug for LCA and 120 ug for RCA) | Drug | Adenosine |
| PlaceboIntracoronary Placebo administration | Drug | Placebo |
Primary outcome
Increase in troponin I (> 3 times the upper normal limit)
Time frame: At 12 hours after the procedure
2 secondary outcomes
MACE(death, MI, urgent target-vessel revascularization)
Time frame: 72 hours
Angiographic Coronary flow, as evaluated by corrected TIMI frame count.
Time frame: 1 minute after the final stent implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2011.
- Derived from this study: PubMed 22000773De Luca G, Iorio S, Venegoni L, Marino P. Evaluation of intracoronary adenosine to prevent periprocedural myonecrosis in elective percutaneous coronary intervention (from the PREVENT-ICARUS Trial). Am J Cardiol. 2012 Jan 15;109(2):202-7. doi: 10.1016/j.amjcard.2011.08.027. Epub 2011 Oct 14.
Related trials for Coronary Angioplasty
Recruiting
Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients.
Renovascular Hypertension, Renovascular Hypertension With Renal Failure
Recruiting
Computational μFR-Guided Versus Angiographic Guidance in Drug-Coated Balloon Angioplasty
Coronary Artery Disease
Active, not recruitingObservational study
Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
Chronic Limb Threatening Ischemia
RecruitingObservational study
Treatment of Primary Coronary Artery Vascular Lesions With Biolimus Coated Coronary Balloon Dilation Catheter
Coronary Artery Disease
Recruiting
Late-lumen Changes After Drug-Coated Balloon Angioplasty Versus Drug-Eluting Stents in De Novo Coronary Lesions
Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe De Luca, MD principal investigator
AOU Maggiore della Carità
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adenosine in people with Coronary Angioplasty, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in troponin I (> 3 times the upper normal limit) (time frame: At 12 hours after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01148147, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2011.