Coronary Artery DiseasePhase 4NCT01706510
Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients
A Phase 4 study testing Ticagrelor and Clopidogrel in people with Coronary Artery Disease, run by Rapid City Regional Hospital, Inc at 1 site in United States.
Trial summary
Assess the pharmacodynamic effect of ticagrelor vs. Clopidogrel in American Indian patients with stable coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Ticagrelor and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Apr 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented stable CAD fulfilling any of the following, and taking 81mg ASA daily treatment:
- Females must be post menopausal for at least one year or surgically sterile for at least 6 months and negative urine pregnancy test
- Self-identified as American Indian
- Genetic Inclusion Criteria: must sign the informed consent for genetic and biological sample banking.
Who cannot join
- Any indication for oral anticoagulant or dual antiplatelet treatment
- Concomitant therapy with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic index, or strong CYP3A inducers within 14 days and during study treatment and during:
- Increased bleeding risk including:
- Diabetic patients with HbAlC > 10% at screening
- Contraindication to clopidogrel, ASA, or ticagrelor - A history of alcohol and/or substance abuse that could interfere with conduct of the trial
- Patients requiring dialysis
Show all 11Show fewer
- Patients scheduled for revascularization (e.g., PCI, CABG) during the study period
- Any acute or chronic unstable condition in the past 30 days
- Known active or recurrent hepatic disorder
- Patients who had ACS or stent placed within 12 months of screening
- History of Uric Acid nephropathy
Trial locations and contacts
1 site in 1 country.
United States1 site
Regional Heart Doctors/Black Hills Cardiovascular Research
Rapid City, South Dakota, 57701
About this study
Official title: A Single Center, Randomized, Open Label, Multiple Dose, Crossover Study of the Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients With Stable Coronary Artery Disease
Assess the pharmacodynamic effect of ticagrelor vs. Clopidogrel in American Indian patients with stable coronary artery disease.
Read the detailed description
A Single Center, Randomized, Open Label, Multiple Dose, Crossover Study of the Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients With Stable Coronary Artery Disease
- Conditions
- Coronary Artery Disease
- Being tested
- Ticagrelor, Clopidogrel
- Keywords
- Clopidogrel, Ticagrelor, Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases, Platelet Aggregation Inhibitors, Hematologic Agents, Therapeutic Uses, Pharmacologic Actions, Purinergic P2Y Receptor Antagonists, Purinergic P2 Receptor Antagonists, Purinergic Antagonists, Purinergic Agents, Physiological Effects of Drugs
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
Also called Brand Name: Brilinta
Ticagrelor 180 mg loading dose followed by 90 mg bid for 7 days ± 2 days
ClopidogrelDrug
Also called Brand Name: Plavix
Clopidogrel 600 mg loading dose followed by 75 mg Daily for 7 days ± 2 days
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor | Experimental | Ticagrelor 180 mg loading dose followed by 90 mg bid for 7 days ± 2 days Receives: Drug: Ticagrelor; Drug: Clopidogrel |
| Clopidogrel | Active comparator | Clopidogrel 600 mg Loading Dose followed by 75 mg Daily for 7 days ± 2 days Receives: Drug: Ticagrelor; Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare ticagrelor's versus clopidogrel's inhibition of the P2Y12 receptor as measured by the decrease in P2Y12 Reaction Units (PRU) using VerifyNow TM.
Measured: At 2 hour time point after loading dose
Secondary outcomes (4)
Compare the decrease of P2Y12 Reaction Units (PRU) by VerifyNow TM from ticagrelor and clopidogrel.
Measured: 0.5 and 8 hour time points after loading dose
Compare the decrease in P2Y l2 Reaction Units (PRU) by VerifyNow™ from ticagrelor's and clopidogrel's morning dose on Day 7
Measured: At the 2, 8, and 24 hours after the last dose
To evaluate and compare the pharmacodynamic effects, measured by the vasodilator-stimulated phosphoprotein (VASP) assay (platelet reactivity index [PRI]), in all subjects
Measured: Day1: pre-dose, 0.5, 2, and 8 hours post loading dose Day 7: pre-dose, 2 and 8 hours post dose Day 8: 24 hours post final dose
Assess and to compare the percentage of subjects with High on-treatment Platelet Reactivity (HPR) at all time points after randomized study treatment.
The High on-treatment Platelet Reactivity will be defined in accordance with the following platelet inhibition level cut-off.
- > 208 PRU by the VerifyNow P2Y12 assay
- > 230 PRU by the VerifyNow P2Y12 assay
- > 50% PRI by the VASP assay
Measured: Day 1: Pre-dose, 0.5, 2 and 8 hours post loading dose Day 7: pre-dose, 2 and 8 hours post dose Day 8: 24 hours after final dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startDec 2012
- Primary completionMar 2014
- Study completionApr 2014
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rapid City Regional Hospital, Inc
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- James S Walder, MD, Principal investigator, Rapid City Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706510
- Sponsor's protocol ID
- ISSBRIL0076
- Status last verified
- May 2015
- First submitted
- 10 Oct 2012
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Open Label, Multiple Dose, Crossover Study of the Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients With Stable Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01706510
- Acronym / sponsor ID
- ISSBRIL0076
- Conditions
- Coronary Artery Disease
- Keywords
- Clopidogrel, Ticagrelor, Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Rapid City Regional Hospital, IncUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Dec 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 15 Oct 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.
Assess the pharmacodynamic effect of ticagrelor vs. Clopidogrel in American Indian patients with stable coronary artery disease.
Detailed description
A Single Center, Randomized, Open Label, Multiple Dose, Crossover Study of the Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients With Stable Coronary Artery Disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor | Experimental | Drug: Ticagrelor, Drug: ClopidogrelTicagrelor 180 mg loading dose followed by 90 mg bid for 7 days ± 2 days |
| Clopidogrel | Active comparator | Drug: Ticagrelor, Drug: ClopidogrelClopidogrel 600 mg Loading Dose followed by 75 mg Daily for 7 days ± 2 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Documented stable CAD fulfilling any of the following, and taking 81mg ASA daily treatment:
- Females must be post menopausal for at least one year or surgically sterile for at least 6 months and negative urine pregnancy test
- Self-identified as American Indian
- Genetic Inclusion Criteria: must sign the informed consent for genetic and biological sample banking.
Key exclusion criteria (11 listed)
- Any indication for oral anticoagulant or dual antiplatelet treatment
- Concomitant therapy with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic index, or strong CYP3A inducers within 14 days and during study treatment and during:
- Increased bleeding risk including:
- Diabetic patients with HbAlC > 10% at screening
- Contraindication to clopidogrel, ASA, or ticagrelor - A history of alcohol and/or substance abuse that could interfere with conduct of the trial
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 |
|---|---|---|
| TicagrelorAlso: Brand Name: BrilintaTicagrelor 180 mg loading dose followed by 90 mg bid for 7 days ± 2 days | Drug | Clopidogrel, Ticagrelor |
| ClopidogrelAlso: Brand Name: PlavixClopidogrel 600 mg loading dose followed by 75 mg Daily for 7 days ± 2 days | Drug | Clopidogrel, Ticagrelor |
Primary outcome
Compare ticagrelor's versus clopidogrel's inhibition of the P2Y12 receptor as measured by the decrease in P2Y12 Reaction Units (PRU) using VerifyNow TM.
Time frame: At 2 hour time point after loading dose
4 secondary outcomes
Compare the decrease of P2Y12 Reaction Units (PRU) by VerifyNow TM from ticagrelor and clopidogrel.
Time frame: 0.5 and 8 hour time points after loading dose
Compare the decrease in P2Y l2 Reaction Units (PRU) by VerifyNow™ from ticagrelor's and clopidogrel's morning dose on Day 7
Time frame: At the 2, 8, and 24 hours after the last dose
To evaluate and compare the pharmacodynamic effects, measured by the vasodilator-stimulated phosphoprotein (VASP) assay (platelet reactivity index [PRI]), in all subjects
Time frame: Day1: pre-dose, 0.5, 2, and 8 hours post loading dose Day 7: pre-dose, 2 and 8 hours post dose Day 8: 24 hours post final dose
Assess and to compare the percentage of subjects with High on-treatment Platelet Reactivity (HPR) at all time points after randomized study treatment.
Time frame: Day 1: Pre-dose, 0.5, 2 and 8 hours post loading dose Day 7: pre-dose, 2 and 8 hours post dose Day 8: 24 hours after final dose
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 5 May 2015.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
James S Walder, MD principal investigator
Rapid City Regional Hospital
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 and Clopidogrel in people with Coronary Artery Disease, run by Rapid City Regional Hospital, Inc 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 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 5 May 2015. 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. 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?
Compare ticagrelor's versus clopidogrel's inhibition of the P2Y12 receptor as measured by the decrease in P2Y12 Reaction Units (PRU) using VerifyNow TM. (time frame: At 2 hour time point after loading dose). 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 5 May 2015.