- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02507323
Ticagrelor vs. Prasugrel Effects on Infarct Size (TIPRIS)
TIPRIS: Ticagrelor vs. Prasugrel Effects on Infarct Size: A Head to Head Comparison With Prasugrel
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Subjects and research staff (including the Magnetic Resonance Imaging (MRI) readers and interventional cardiologists) will not know what active treatment study drug the subjects are receiving.
Study Arm 1: Ticagrelor (180 mg loading dose, followed by 90 mg twice a day) PO plus matching placebo
Study Arm 2: Prasugrel (60 mg loading dose followed by 5 or 10 mg once per day based on weight) PO plus matching placebo
Additional study drug: Aspirin (81mg per day)
Participation in this study will be about 90 days and includes 4 study visits (other than your hospital stay) and 3 telephone calls.
ENROLLMENT PROCEDURES:
The following procedures are to be completed after informed consent has been obtained:
- Informed Consent Form signed
- Medical history
- Vital signs (eg, blood pressure, heart rate, respiration rate, temperature)
- Review for Adverse Events (AEs) and Serious Adverse Events (SAEs) (only AEs possibly related to study procedures and SAEs are collected)
- Documentation of concomitant medications
- Physical exam
- Body height
- Body weight
- 12-lead Electrocardiogram (ECG)
- Angiographic and Percutaneous Coronary Intervention (PCI) data
- Randomization of treatment assignment
- Investigational product dispensing (on Day 0 and during hospital stay) - Loading dose on Day 0 - 3 day investigational product dosing while in the hospital - 30 day supply dispensing of investigational product on Day 3 for subject to take home
- Local laboratory Assessments: - Blood draw for Creatine Kinase-MB (CK-MB) and troponin I - Blood pregnancy (females of childbearing potential only)
FOLLOW UP PROCEDURES:
Day 5
- Vital signs (e.g., blood pressure, heart rate, respiration rate, temperature)
- Review for Adverse Events and Serious Adverse Events (only AEs possibly related to study procedures and SAEs are collected)
- Cardiac MRI
- Left Ventricular Ejection Fraction (LVEF), Left Ventricular End-Diastolic Volume (LVEDV), Left Ventricular End-Systolic Volume (LVESV) calculations
- Serum creatinine, Complete Blood Count (CBC)
- Documentation of concomitant medications and investigational product compliance
Day 30 (+/- 1 day), Day 60 (+/- 2 days)
- Vital signs (e.g., blood pressure, heart rate, respiration rate, temperature)
- Review for Adverse Events and Serious Adverse Events (only AEs possibly related to study procedures and SAEs are collected)
- LVEF, LVEDV, LVESV calculations
- Serum creatinine, CBC
- Documentation of concomitant medications and investigational product compliance
- Investigational Product Dispensing
Day 14, Day 44, Day 74 (+/- 2 days):
Phone calls will be performed to ensure drug compliance, review concomitant medications and review any events. On Day 74, study staff will confirm whether or not the subject has seen their regular cardiologist. Subject will be instructed to bring this information with them at the Day 90 visit so that their cardiologist can be told what arm they participated in for continuation of care and medication therapy.
Day 90 or Termination/End of Study (+/- 2 days) :
- Vital signs (eg, sitting blood pressure, heart rate, respiration rate, temperature)
- Review for Adverse Events and Serious Adverse Events (only AEs possibly related to study procedures and SAEs are collected)
- Cardiac MRI
- LVEF, LVEDV, LVESV calculations
- Serum creatinine, CBC
- Documentation of concomitant medications and investigational product compliance
- If available and subject consents, subject's cardiologist will be informed what arm of the study they participated in for continuation of care and medication therapy.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Houston Methodist Hospital
-
Houston, Texas, United States, 77030
- Memorial Hermann Hospital
-
Houston, Texas, United States, 77030
- Baylor-St. Lukes Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Informed consent: Signed informed consent prior to any study specific procedures
- Age: Male and females aged 18 years and older
- Onset: Presenting to emergency room or cardiac catheterization laboratory within 6 hours of onset of myocardial infarction symptoms
- Continuing to have ongoing myocardial infarction symptoms
- EKG findings: ST elevation on ECG with positive T waves in the precordial leads, suggestive of anterior STEMI
- Triaged for emergency cardiac catheterization (primary PCI protocol)
- Agree to use an effective contraceptive method beginning at the signing of the informed consent and for at least 30 days after the last dose of study drug. The definition of an effective method of contraception will be based on the judgment of the investigator.
Exclusion Criteria:
- Prior myocardial infarction
- Contraindication to ticagrelor and/or prasugrel
- Contraindication to gadolinium
- Contraindication to aspirin
- Treatment with fibrinolytic therapy for the index STEMI
- High risk of bleeding
- Presenting with cardiogenic shock
- Infarction due to stent thrombosis
- History of a previous coronary artery bypass graft (CABG)
- Known renal insufficiency (acute kidney injury or Glomerular Filtration Rate < 40 mL/min/1.73 m2).
- Moderate or severe hepatic impairment
- Inability to undergo cardiac MRI
- Indication for aspirin >162 mg/d
- Indication for Nonsteroidal Anti-Inflammatory Drugs or COX2 inhibitors
- Pregnant
- Breast feeding
- History of intracranial hemorrhage
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ticagrelor or matching placebo
ticagrelor (180 mg loading followed by 90 mg twice daily) or matching placebo
|
placebo
A platelet aggregation inhibitor
Other Names:
|
Active Comparator: prasugrel or matching placebo
prasugrel (60 mg loading followed by 5-10 mg/d) or matching placebo
|
placebo
a thienopyridine class inhibitor of platelet activation and aggregation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy as measured by infarct size on all randomized patients.
Time Frame: up to Day 90
|
up to Day 90
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety as measured by incidences of treatment emergent adverse events, serious adverse events, treatment-related adverse events and adverse events leading to stop of drug
Time Frame: 90 days
|
for 90 day major adverse cardiac events and bleeding complications
|
90 days
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Platelet Aggregation Inhibitors
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Ticagrelor
- Prasugrel Hydrochloride
Other Study ID Numbers
- 34665: Ticagrelor v Prasugrel
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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