CV004-007 Thrombosis Chamber Study
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ClinicalTrials.gov Identifier: NCT02439190 |
Recruitment Status :
Completed
First Posted : May 8, 2015
Last Update Posted : September 8, 2016
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Condition or disease | Intervention/treatment | Phase |
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Thrombosis | Drug: BMS-986120 Drug: Aspirin Drug: Clopidogrel | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 42 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Official Title: | A Single Dose Study to Evaluate the Effect of BMS-986120 on Thrombus Formation in an Ex Vivo Thrombosis Chamber Model in Healthy Subjects |
Study Start Date : | September 2015 |
Actual Primary Completion Date : | March 2016 |
Actual Study Completion Date : | March 2016 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Treatment A: BMS-986120
BMS-986120 on specified days
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Drug: BMS-986120 |
Active Comparator: Treatment B: Aspirin and Clopidogrel
Aspirin and Clopidogrel on specified days
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Drug: Aspirin Drug: Clopidogrel |
- Change from baseline in thrombus area (post-treatment with BMS-986120 vs. pre-treatment) [ Time Frame: 2 days ]
- Safety and tolerability of BMS 986120 or aspirin administered with and without clopidogrel based on adverse events,clinical laboratory tests, physical examinations and vital signs per the collection schedule [ Time Frame: 2 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations
- Body Mass Index (BMI) of 18 to 32 kg/m2 inclusive. BMI = weight (kg)/ [height (m)]2
- Females who are not of childbearing potential (i.e., who are post-menopausal or surgically sterile) and men ages 18 to 65, inclusive
- Azoospermic males and women who are not of child-bearing potential (i.e. are postmenopausal or surgically sterile; see section 3.3.3 for the definition of WOCBP) are exempt from contraceptive requirements. However, women must still undergo pregnancy testing as described in this section
Exclusion Criteria:
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
- Any condition that could affect drug absorption
- Other protocol-defined exclusion criteria could apply

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439190
United Kingdom | |
Local Institution | |
Edinburgh, Scotland, United Kingdom, EH16 4SA |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT02439190 |
Other Study ID Numbers: |
CV004-007 |
First Posted: | May 8, 2015 Key Record Dates |
Last Update Posted: | September 8, 2016 |
Last Verified: | April 2016 |
Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Aspirin Clopidogrel BMS-986120 Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents |
Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents |