HealthyPhase 4NCT01996735
Ticagrelor and Adenosine
A Phase 4 study testing Ticagrelor 180 mg single dose in people with Healthy, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Preclinical studies have shown that the P2Y12 receptor antagonist ticagrelor can increase the extracellular concentration of the endogenous nucleoside adenosine by inhibiting the cellular uptake of adenosine via the equilibrative nucleoside transporter (ENT). Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ticagrelor 180 mg single dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2013to Dec 2013
- Phase
- Phase 4
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male sex
- Age 18-40 years
- Healthy
- Written informed consent
Who cannot join
- Smoking
- Hypertension (Blood pressure >140 mmHg and/or >90 mmHg - SBP/DBP-)
- Diabetes Mellitus (fasting glucose > 7.0 mmol/L or random > 11.0 mmol/L)
- History of any cardiovascular disease
- History of chronic obstructive pulmonary disease (COPD) or asthma
- Bleeding tendency
Show all 11Show fewer
- Concomitant use of medication
- Renal dysfunction (MDRD < 60 ml/min)
- Liver enzyme abnormalities (ALAT > twice upper limit of normality)
- Thrombocytopenia (<150*109/ml)
- Second/third degree AV-block on electrocardiography
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6500 HB
About this study
Official title: The Effect of Ticagrelor on the Adenosine System
Preclinical studies have shown that the P2Y12 receptor antagonist ticagrelor can increase the extracellular concentration of the endogenous nucleoside adenosine by inhibiting the cellular uptake of adenosine via the equilibrative nucleoside transporter (ENT). This mechanism can contribute to the beneficial effects and to the side effects (dyspnea) of ticagrelor in patients with an acute myocardial infarction. In the current research proposal, we aim to investigate whether ticagrelor increases adenosine receptor stimulation in humans in vivo by ENT inhibition.
- Conditions
- Healthy
- Being tested
- Ticagrelor 180 mg single dose, Placebo
- Keywords
- Endothelial function, Adenosine receptor stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ticagrelor 180 mg single doseDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor 180 mg single dose | Active comparator | Ticagrelor 180 mg single dose Receives: Drug: Ticagrelor 180 mg single dose |
| Placebo | Placebo comparator | Placebo single dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forearm blood flow response
Forearm blood flow response to the intrabrachial administration of incremental dosages of adenosine, after treatment with ticagrelor compared to placebo. The forearm blood flow will be measured by plethysmography.
Measured: 2 hours after intake of ticagrelor/placebo
Forearm blood flow response
Directly after 2 and 5 minutes of forearm ischemia.The forearm blood flow will be measured by plethysmography.
Measured: Directly after 2 and 5 minutes of forearm ischemia
Secondary outcomes (2)
Forearm blood flow respons
Forearm blood flow response to the intrabrachial administration of incremental dosages of dipyridamole, after treatment with ticagrelor compared to placebo. The forearm blood flow will be measured by plethysmography
Measured: Directly after administration of dipyridamole
ex-vivo adenosine uptake in isolated erythrocytes
To study whether ticagrelor inhibits the ex-vivo adenosine uptake in isolated erythrocytes
Measured: 2 hours after intake of studymedication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startApr 2013
- Primary completionNov 2013
- Study completionDec 2013
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 HealthyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- N. Riksen, MD, PhD, Principal investigator, Radboud University Medical CenterG. Rongen, MD, PhD, Principal investigator, Radboud University Medical CenterM. Gomes, MD, PhD, Principal investigator, Dept Cardiology, Canisius Wilhelmina Hospital NijmegenS. El Messaoudi, MD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996735
- Sponsor's protocol ID
- NL43379.091.13
- Status last verified
- Feb 2013
- First submitted
- 26 Apr 2013
- Last updated
- 10 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
van den Berg TN, El Messaoudi S, Rongen GA, van den Broek PH, Bilos A, Donders AR, Gomes ME, Riksen NP. Ticagrelor Does Not Inhibit Adenosine Transport at Relevant Concentrations: A Randomized Cross-Over Study in Healthy Subjects In Vivo. PLoS One. 2015 Oct 28;10(10):e0137560. doi: 10.1371/journal.pone.0137560. eCollection 2015.
PubMed 26509673
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ticagrelor on the Adenosine System
- ClinicalTrials.gov ID
- NCT01996735
- Acronym / sponsor ID
- NL43379.091.13
- Conditions
- Healthy
- Keywords
- Endothelial function, Adenosine receptor stimulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 Nov 2013 (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.
Preclinical studies have shown that the P2Y12 receptor antagonist ticagrelor can increase the extracellular concentration of the endogenous nucleoside adenosine by inhibiting the cellular uptake of adenosine via the equilibrative nucleoside transporter (ENT). This mechanism can contribute to the beneficial effects and to the side effects (dyspnea) of ticagrelor in patients with an acute myocardial infarction. In the current research proposal, we aim to investigate whether ticagrelor increases adenosine receptor stimulation in humans in vivo by ENT inhibition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor 180 mg single dose | Active comparator | Drug: Ticagrelor 180 mg single doseTicagrelor 180 mg single dose |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo single dose |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male sex
- Age 18-40 years
- Healthy
- Written informed consent
Key exclusion criteria (11 listed)
- Smoking
- Hypertension (Blood pressure >140 mmHg and/or >90 mmHg - SBP/DBP-)
- Diabetes Mellitus (fasting glucose > 7.0 mmol/L or random > 11.0 mmol/L)
- History of any cardiovascular disease
- History of chronic obstructive pulmonary disease (COPD) or asthma
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 |
|---|---|---|
| Ticagrelor 180 mg single dose | Drug | Ticagrelor 180 mg single dose |
| Placebo | Drug | Placebo |
Primary outcome
Forearm blood flow response
Time frame: 2 hours after intake of ticagrelor/placebo
Forearm blood flow response to the intrabrachial administration of incremental dosages of adenosine, after treatment with ticagrelor compared to placebo. The forearm blood flow will be measured by plethysmography.
Forearm blood flow response
Time frame: Directly after 2 and 5 minutes of forearm ischemia
Directly after 2 and 5 minutes of forearm ischemia.The forearm blood flow will be measured by plethysmography.
2 secondary outcomes
Forearm blood flow respons
Time frame: Directly after administration of dipyridamole
ex-vivo adenosine uptake in isolated erythrocytes
Time frame: 2 hours after intake of studymedication
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 10 Jan 2014.
- Derived from this study: PubMed 26509673van den Berg TN, El Messaoudi S, Rongen GA, van den Broek PH, Bilos A, Donders AR, Gomes ME, Riksen NP. Ticagrelor Does Not Inhibit Adenosine Transport at Relevant Concentrations: A Randomized Cross-Over Study in Healthy Subjects In Vivo. PLoS One. 2015 Oct 28;10(10):e0137560. doi: 10.1371/journal.pone.0137560. eCollection 2015.
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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.
N. Riksen, MD, PhD principal investigator
Radboud University Medical Center
G. Rongen, MD, PhD principal investigator
Radboud University Medical Center
M. Gomes, MD, PhD principal investigator
Dept Cardiology, Canisius Wilhelmina Hospital Nijmegen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ticagrelor 180 mg single dose in people with Healthy, run by Radboud University Medical Center at 1 site in Netherlands.
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 11 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 10 Jan 2014. 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 Netherlands. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Forearm blood flow response (time frame: 2 hours after intake of ticagrelor/placebo). The study lists 2 primary outcomes in all. 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 NCT01996735, 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 10 Jan 2014.