Coronary Artery StenosisPhase 3NCT00612521
Prophylactic Intra-coronary Adenosine to Prevent Post Coronary Artery Stenting Myonecrosis
A Phase 3 study testing Adenosine in people with Coronary Artery Stenosis and Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial summary
Myocardial damage occurs in up to 40% of cases when sensitive biomarkers are measured after coronary artery stenting. Such events have been associated with poor outcomes both at 30 days and long term. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Stenosis, Coronary Artery Disease
- What is being tested?
- Adenosine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2007to Sep 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing percutaneous coronary balloon angioplasty and stenting
- Ages 18 years and older
- TIMI III flow on the initial angiography
- Native coronary artery lesions
Who cannot join
- Patients unable to give consent
- Adenosine allergy
- Severe asthma with bronchial reactivity
- Cardiogenic or circulatory shock
- Acute or chronic total coronary artery occlusions
- Patients requiring Rotablator therapy
Show all 12Show fewer
- In stent restenosis
- Second or third degree AV block without a permanent pacemaker
- ST-Elevation MI
- Elevated baseline CK/ CK-MB or troponin levels (Pre-existing Non-STemi)
- Current pregnancy
- Patients not already on statin therapy or intolerant of statins
Trial locations and contacts
1 site in 1 country.
About this study
Myocardial damage occurs in up to 40% of cases when sensitive biomarkers are measured after coronary artery stenting. Such events have been associated with poor outcomes both at 30 days and long term. The cause of such damage is multi-factorial and includes distal propagation of atheromatous and thrombotic debris and the subsequent infiltration of the microcirculation with inflammatory cells. Individually or together these events can occlude the micro-circulation and lead impaired blood flow to heart muscle.
The vasodilator adenosine is commonly used in cases of impaired flow in an endeavor to improve flow rate and limit myocardial damage. Unfortunately the efficacy of this therapy is limited. More recently, there have been clinical studies looking at the administration of adenosine before any potential damage by ballooning or stenting, in an effort to avoid poor distal flow post procedure and thus limit any myocardial damage. Although small numbers of subjects have been included in these trials, there have been encouraging preliminary data.
The aim of this study is to assess whether the use of intra-coronary adenosine given directly into the target coronary artery prior to stenting can reduce the incidence of myonecrosis (heart muscle damage)over placebo. We also aim to assess whether this translates to better outcomes at 30 day follow up.
Read the detailed description
Prior clinical studies looking at the administration of adenosine before coronary artery stenting have looked at small numbers of subjects and did not mandate previous statin therapy or high dose loading of clopidogrel before stenting, both of which can also help lower the rate of peri-procedural myonecrosis.
Our aim is to assess the above mentioned therapy in patients on optimal treatment with statins, dual antiplatelet agents and standard of care anti-coagulants.
- Conditions
- Coronary Artery Stenosis, Coronary Artery Disease
- Being tested
- Adenosine
- Keywords
- Coronary artery disease, Coronary artery stenting, peri-procedural myonecrosis, Adenosine
- Medical subject headings
- Coronary Stenosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdenosineDrug
For lesions in the left coronary system the patient will receive either 120 micrograms of adenosine in 20 mls of normal saline or placebo prior to the wiring, pre-dilatation, stenting and post-dilatation of the target coronary stenosis. For lesions in the right coronary system the patient will receive either 60 micrograms of adenosine in 10 mls of normal saline or placebo prior to the wiring, pre-dilatation, stenting and post-dilatation of the target coronary stenosis.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Either Placebo or Adenosine mixed with normal saline at a concentration of 6 micrograms per milliliter. Receives: Drug: Adenosine |
| 2 | Other | Either Placebo or Adenosine mixed with normal saline at a concentration of 6 micrograms per milliliter. Receives: Drug: Adenosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-procedural myocardial infarction
Measured: 24 hours post procedure
Secondary outcomes (2)
TIMI frame count
Measured: Final angiographic picture during the index procedure
Death, myocardial infarction or target lesion revascularization
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startAug 2007
- Primary completionAug 2008
- Study completionSep 2008
Why it stopped: At half the sample size, the results were negative with no benefit demonstrated with adenosine.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery StenosisStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marino Labinaz, MD FRCP, Principal investigator, Director of Interventional Cardiology - University of Ottawa Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00612521
- Sponsor's protocol ID
- 2007446-01H
- Status last verified
- Aug 2012
- First submitted
- 25 Jan 2008
- Last updated
- 29 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Intra-coronary Adenosine to Prevent Post Coronary Artery Stenting Myonecrosis
- ClinicalTrials.gov ID
- NCT00612521
- Acronym / sponsor ID
- 2007446-01H
- Conditions
- Coronary Artery Stenosis, Coronary Artery Disease
- Keywords
- Coronary artery disease, Coronary artery stenting, peri-procedural myonecrosis, Adenosine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: At half the sample size, the results were negative with no benefit demonstrated with adenosine.
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 11 Feb 2008 (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.
Myocardial damage occurs in up to 40% of cases when sensitive biomarkers are measured after coronary artery stenting. Such events have been associated with poor outcomes both at 30 days and long term. The cause of such damage is multi-factorial and includes distal propagation of atheromatous and thrombotic debris and the subsequent infiltration of the microcirculation with inflammatory cells. Individually or together these events can occlude the micro-circulation and lead impaired blood flow to heart muscle.
The vasodilator adenosine is commonly used in cases of impaired flow in an endeavor to improve flow rate and limit myocardial damage. Unfortunately the efficacy of this therapy is limited. More recently, there have been clinical studies looking at the administration of adenosine before any potential damage by ballooning or stenting, in an effort to avoid poor distal flow post procedure and thus limit any myocardial damage. Although small numbers of subjects have been included in these trials, there have been encouraging preliminary data.
The aim of this study is to assess whether the use of intra-coronary adenosine given directly into the target coronary artery prior to stenting can reduce the incidence of myonecrosis (heart muscle damage)over placebo. We also aim to assess whether this translates to better outcomes at 30 day follow up.
Detailed description
Prior clinical studies looking at the administration of adenosine before coronary artery stenting have looked at small numbers of subjects and did not mandate previous statin therapy or high dose loading of clopidogrel before stenting, both of which can also help lower the rate of peri-procedural myonecrosis.
Our aim is to assess the above mentioned therapy in patients on optimal treatment with statins, dual antiplatelet agents and standard of care anti-coagulants.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: AdenosineEither Placebo or Adenosine mixed with normal saline at a concentration of 6 micrograms per milliliter. |
| 2 | Other | Drug: AdenosineEither Placebo or Adenosine mixed with normal saline at a concentration of 6 micrograms per milliliter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing percutaneous coronary balloon angioplasty and stenting
- Ages 18 years and older
- TIMI III flow on the initial angiography
- Native coronary artery lesions
Key exclusion criteria (12 listed)
- Patients unable to give consent
- Adenosine allergy
- Severe asthma with bronchial reactivity
- Cardiogenic or circulatory shock
- Acute or chronic total coronary artery occlusions
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 |
|---|---|---|
| AdenosineFor lesions in the left coronary system the patient will receive either 120 micrograms of adenosine in 20 mls of normal saline or placebo prior to the wiring, pre-dilatation, stenting and post-dilatation of the target coronary stenosis. For lesions in the right coronary system the patient will receive either 60 micrograms of adenosine in 10 mls of normal saline or placebo prior to the wiring, pre-dilatation, stenting and post-dilatation of the target coronary stenosis. | Drug | 1, 2 |
Primary outcome
Peri-procedural myocardial infarction
Time frame: 24 hours post procedure
2 secondary outcomes
TIMI frame count
Time frame: Final angiographic picture during the index procedure
Death, myocardial infarction or target lesion revascularization
Time frame: 30 days
Results and safety
The study was stopped early (reason given: At half the sample size, the results were negative with no benefit demonstrated with adenosine.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2012.
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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.
Marino Labinaz, MD FRCP principal investigator
Director of Interventional Cardiology - University of Ottawa Heart Institute
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 Artery Stenosis and Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
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 4 inclusion and 12 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: stopped early, as of the sponsor's last update on 29 Aug 2012. 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 Canada. 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. 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 was stopped early (reason given: At half the sample size, the results were negative with no benefit demonstrated with adenosine.). Results are not available in the source record.
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?
Peri-procedural myocardial infarction (time frame: 24 hours post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2012.