Coronary Artery DiseasePhase 1NCT01690884
Effect of Ticagrelor vs. Dipyridamole on Adenosine Uptake
A Phase 1 study testing Adenosine in people with Coronary Artery Disease, run by Vanderbilt University at 1 site in United States.
Trial summary
The investigators are trying to determine if a single dose of Ticagrelor will increase delivery of intraarterially-infused adenosine into the forearm interstitium, consistent with adenosine reuptake blockade. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Adenosine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jan 2017
- Phase
- Phase 1
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects will be healthy volunteers, without significant pulmonary, cardiovascular gastrointestinal, hematological or renal diseases
- Not taking any regular medications
- Able to provide signed consent prior to study participation.
Who cannot join
- History of asthma
- Pregnancy
- Exposure to an investigational drug in the last 2 months.
- Known hypersensitivity to study medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Autonomic Dysfunction Center
Nashville, Tennessee, 37232
About this study
Official title: Ticagrelor and Adenosine Uptake. Phase II Study Comparing the Effects of Ticagrelor vs Dipyridamole on Adenosine Uptake
The investigators are trying to determine if a single dose of Ticagrelor will increase delivery of intraarterially-infused adenosine into the forearm interstitium, consistent with adenosine reuptake blockade.
Read the detailed description
The investigators will compare adenosine interstitial levels using a parallel design study with three groups of subjects. Forearm interstitial adenosine levels will be measured at baseline and after intrabrachial infusion of adenosine at two doses. Subjects will then randomly receive Ticagrelor 180 mg, Dipyridamole 200 mg, or placebo. Two hours later the investigators will repeat the dialysate collections at baseline and after adenosine infusions.
- Conditions
- Coronary Artery Disease
- Being tested
- Adenosine
- Keywords
- Adenosine, Ticagrelor, Microdialysis
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdenosineDrug
Also called Adenocard
Adenosine will be infused into the brachial artery at 0.125 mg/min for 15 minutes and then at 0.5 mg/min for an additional 15 minutes,
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | To determine if there is an increase in adenosine interstitial levels in the forearm. Receives: Drug: Adenosine |
| Dipyridamole | Active comparator | To determine if there is an increase in adenosine interstitial levels in the forearm. Receives: Drug: Adenosine |
| Ticagrelor | Experimental | To determine if there is an increase in adenosine interstitial levels in the forearm. Receives: Drug: Adenosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interstitial levels of adenosine
Measured: After each dose of intrabrachial adenosine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Italo Biaggioni, Vanderbilt University
- Investigators
- Italo Biaggioni, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690884
- Sponsor's protocol ID
- 120477
- Status last verified
- Feb 2018
- First submitted
- 27 Aug 2012
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ticagrelor and Adenosine Uptake. Phase II Study Comparing the Effects of Ticagrelor vs Dipyridamole on Adenosine Uptake
- ClinicalTrials.gov ID
- NCT01690884
- Acronym / sponsor ID
- 120477
- Conditions
- Coronary Artery Disease
- Keywords
- Adenosine, Ticagrelor, Microdialysis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 24 Sep 2012 (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.
The investigators are trying to determine if a single dose of Ticagrelor will increase delivery of intraarterially-infused adenosine into the forearm interstitium, consistent with adenosine reuptake blockade.
Detailed description
The investigators will compare adenosine interstitial levels using a parallel design study with three groups of subjects. Forearm interstitial adenosine levels will be measured at baseline and after intrabrachial infusion of adenosine at two doses. Subjects will then randomly receive Ticagrelor 180 mg, Dipyridamole 200 mg, or placebo. Two hours later the investigators will repeat the dialysate collections at baseline and after adenosine infusions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: AdenosineTo determine if there is an increase in adenosine interstitial levels in the forearm. |
| Dipyridamole | Active comparator | Drug: AdenosineTo determine if there is an increase in adenosine interstitial levels in the forearm. |
| Ticagrelor | Experimental | Drug: AdenosineTo determine if there is an increase in adenosine interstitial levels in the forearm. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects will be healthy volunteers, without significant pulmonary, cardiovascular gastrointestinal, hematological or renal diseases
- Not taking any regular medications
- Able to provide signed consent prior to study participation.
Key exclusion criteria (4 listed)
- History of asthma
- Pregnancy
- Exposure to an investigational drug in the last 2 months.
- Known hypersensitivity to study medications
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 |
|---|---|---|
| AdenosineAlso: AdenocardAdenosine will be infused into the brachial artery at 0.125 mg/min for 15 minutes and then at 0.5 mg/min for an additional 15 minutes, | Drug | Dipyridamole, Placebo, Ticagrelor |
Primary outcome
Interstitial levels of adenosine
Time frame: After each dose of intrabrachial adenosine
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 28 Feb 2018.
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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.
Italo Biaggioni, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Adenosine in people with Coronary Artery Disease, run by Vanderbilt University at 1 site in United States.
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 3 inclusion and 4 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 28 Feb 2018. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Interstitial levels of adenosine (time frame: After each dose of intrabrachial adenosine). 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 28 Feb 2018.