Differential Effect of Ticagrelor Versus Prasugrel on the Adenosine-induced Coronary Vasodilatory Responses in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention
This study has been completed.
Sponsor:
University of Patras
Information provided by (Responsible Party):
Dimitrios Alexopoulos, University of Patras
ClinicalTrials.gov Identifier:
NCT01642966
First received: July 12, 2012
Last updated: January 21, 2013
Last verified: January 2013
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Purpose
This is a prospective, randomized, single-blind, investigator-initiated, crossover study. Patients with Acute Coronary Syndrome (ACS) subjected to percutaneous coronary intervention (PCI), are randomized after informed consent, in a 1:1 ratio to either ticagrelor 90mg x2 or prasugrel 10mg x1 for 15 days. At Day 15± 2 days, coronary diastolic blood flow velocity in left anterior descending artery (LAD) is evaluated at baseline (bCBFV) and under 2 min adenosine infusions (maximal diastolic CBFV- maxCBFV) at gradually increasing doses of 50μg/kg/min, 80μg/kg/min, 110μg/kg/min and 140μg/kg/min with at least 5 min recovery intervals between infusions. A crossover directly to the alternate treatment is performed followed by the same evaluation at Day 30±2 days .
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Coronary Syndrome |
Drug: Prasugrel Drug: Ticagrelor |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Differential Effect of Ticagrelor Versus Prasugrel on the Adenosine-induced Coronary Vasodilatory Responses in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention. |
Resource links provided by NLM:
Further study details as provided by University of Patras:
Primary Outcome Measures:
- The area under the curve (AUC) of the maxCBFV (maximal diastolic blood flow velocity in left anterior descending artery)at gradually increasing doses of adenosine [ Time Frame: 15 days ] [ Designated as safety issue: No ]The primary outcome will be assessed 15 days after the onset of each study drug
Secondary Outcome Measures:
- The ratio of maximal diastolic blood flow velocity in left anterior descending artery/baseline diastolic blood flow velocity in left anterior descending artery for 50μg/kg/min adenosine infusion at the end of treatment periods [ Time Frame: 15 days ] [ Designated as safety issue: No ]
- The ratio of maximal diastolic blood flow velocity in left anterior descending artery/baseline diastolic blood flow velocity in left anterior descending artery for 80μg/kg/min adenosine infusion at the end of treatment periods [ Time Frame: 15 days ] [ Designated as safety issue: No ]
- The ratio of maximal diastolic blood flow velocity in left anterior descending artery/baseline diastolic blood flow velocity in left anterior descending artery for 110μg/kg/min adenosine infusion at the end of treatment periods [ Time Frame: 15 days ] [ Designated as safety issue: No ]
- The ratio of maximal diastolic blood flow velocity in left anterior descending artery/baseline diastolic blood flow velocity in left anterior descending artery for 140μg/kg/min adenosine infusion at the end of treatment periods [ Time Frame: 15 days ] [ Designated as safety issue: No ]
| Enrollment: | 56 |
| Study Start Date: | September 2012 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Prasugrel
Prasugrel 10mg/day for 15 days
|
Drug: Prasugrel
Prasugrel 10mg/day for 15 days
|
|
Experimental: Ticagrelor
Ticagrelor 90mg twice a day for 15 days
|
Drug: Ticagrelor
Ticagrelor 90mg twice a day for 15 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 18-74 years
- Patients with acute coronary syndrome undergoing PCI with stenting
- Sinus rhythm
- Written informed consent
Exclusion Criteria:
- Known hypersensitivity to prasugrel or ticagrelor
- Requirement for oral anticoagulant prior to the Day 30 visit
- Any previous history of ischemic stroke, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm)
- Any active bleeding or history of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 3 months, other bleeding diathesis, or considered by investigator to be at high risk for bleeding
- Concomitant oral or IV therapy with strong CY P3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazana vir, grapefruit juice N1 L/d), CYP3A substrates with narrow therapeutic indices (cyclosporine, quinidine), or strong CYP3A inducers (rifampin /rifampicin, phenytoin, carbamazepine).
- Increased risk of bradycardiac events.
- Dialysis required.
- Severe uncontrolled chronic obstructive pulmonary disease
- Known severe hepatic impairment
- Pregnancy or breastfeeding
- Left ventricular ejection fraction < 45%, severe left ventricular hypertrophy, diastolic dysfunction, severe valve disease
- Prior myocardial infarction, percutaneous coronary intervention or coronary artery bypass grafting
- Weight < 60 Kg
- Alcohol or narcotics abuse
- Major periprocedural complications: death, cardiogenic shock, stent thrombosis, arrhythmias requiring cardioversion/defibrillation, temporary pacemaker insertion or intravenous antiarrhythmic agents, respiratory failure requiring intubation, retroperitoneal bleeding, major bleeding (need for blood transfusion or drop in haemoglobin post-PCI by ≥ 5 gr/ dl or intracranial bleeding), unsuccessful PCI (residual stenosis > 30% or flow < ΤΙΜΙ 3) or planned staged PCI in the next 5 days after randomization
- Any residual stenosis > 40% in LAD
- Small vessels or diffuse coronary atherosclerosis
- Inability to detect coronary blood flow in LAD
Contacts and Locations More Information
No publications provided
| Responsible Party: | Dimitrios Alexopoulos, Professor of Cardiology, Director of Cardiology Department, University of Patras |
| ClinicalTrials.gov Identifier: | NCT01642966 History of Changes |
| Other Study ID Numbers: | PATRASCARDIOLOGY-12 |
| Study First Received: | July 12, 2012 |
| Last Updated: | January 21, 2013 |
| Health Authority: | Greece: Ethics Committee |
Keywords provided by University of Patras:
|
ticagrelor doppler echocardiography |
Additional relevant MeSH terms:
|
Acute Coronary Syndrome Myocardial Ischemia Heart Diseases Cardiovascular Diseases Angina Pectoris Vascular Diseases Chest Pain Pain Signs and Symptoms Adenosine Prasugrel Ticagrelor Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents Vasodilator Agents Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013