Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-01-19 @ 1:58 AM
Study NCT ID:
NCT01996735
Status:
COMPLETED
Last Update Posted:
2014-01-10
First Post:
2013-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ticagrelor and Adenosine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077486', 'term': 'Ticagrelor'}], 'ancestors': [{'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-09', 'studyFirstSubmitDate': '2013-04-26', 'studyFirstSubmitQcDate': '2013-11-21', 'lastUpdatePostDateStruct': {'date': '2014-01-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forearm blood flow response', 'timeFrame': '2 hours after intake of ticagrelor/placebo', 'description': '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.'}, {'measure': 'Forearm blood flow response', 'timeFrame': 'Directly after 2 and 5 minutes of forearm ischemia', 'description': 'Directly after 2 and 5 minutes of forearm ischemia.The forearm blood flow will be measured by plethysmography.'}], 'secondaryOutcomes': [{'measure': 'Forearm blood flow respons', 'timeFrame': 'Directly after administration of dipyridamole', 'description': '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'}, {'measure': 'ex-vivo adenosine uptake in isolated erythrocytes', 'timeFrame': '2 hours after intake of studymedication', 'description': 'To study whether ticagrelor inhibits the ex-vivo adenosine uptake in isolated erythrocytes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Endothelial function', 'Adenosine receptor stimulation'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '26509673', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male sex\n* Age 18-40 years\n* Healthy\n* Written informed consent\n\nExclusion Criteria:\n\n* Smoking\n* Hypertension (Blood pressure \\>140 mmHg and/or \\>90 mmHg - SBP/DBP-)\n* Diabetes Mellitus (fasting glucose \\> 7.0 mmol/L or random \\> 11.0 mmol/L)\n* History of any cardiovascular disease\n* History of chronic obstructive pulmonary disease (COPD) or asthma\n* Bleeding tendency\n* Concomitant use of medication\n* Renal dysfunction (MDRD \\< 60 ml/min)\n* Liver enzyme abnormalities (ALAT \\> twice upper limit of normality)\n* Thrombocytopenia (\\<150\\*109/ml)\n* Second/third degree AV-block on electrocardiography'}, 'identificationModule': {'nctId': 'NCT01996735', 'briefTitle': 'Ticagrelor and Adenosine', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'The Effect of Ticagrelor on the Adenosine System', 'orgStudyIdInfo': {'id': 'NL43379.091.13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ticagrelor 180 mg single dose', 'description': 'Ticagrelor 180 mg single dose', 'interventionNames': ['Drug: Ticagrelor 180 mg single dose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo single dose', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ticagrelor 180 mg single dose', 'type': 'DRUG', 'armGroupLabels': ['Ticagrelor 180 mg single dose']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500 HB', 'city': 'Nijmegen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Radboud University Nijmegen Medical Centre', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'N. Riksen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}, {'name': 'G. Rongen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}, {'name': 'M. Gomes, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept Cardiology, Canisius Wilhelmina Hospital Nijmegen'}, {'name': 'S. El Messaoudi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}