---
title: The Effect of Ticagrelor With or Without Atorvastatin on Endothelial Function in Healthy Males
nct_id: NCT02910778
overall_status: COMPLETED
phase: PHASE4
sponsor: Medical University of Vienna
study_type: INTERVENTIONAL
primary_condition: Ischemia
countries: Austria
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02910778.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02910778"
ct_last_update_post_date: 2017-03-22
last_seen_at: "2026-05-12T06:45:45.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The Effect of Ticagrelor With or Without Atorvastatin on Endothelial Function in Healthy Males

**Official Title:** A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Effect of Atorvastatin Treatment for 14 Days in Combination With an Acute Dose of Ticagrelor on Ischemia Reperfusion Induced Endothelial Dysfunction of the Forearm Vasculature in Healthy Male Subjects

**NCT ID:** [NCT02910778](https://clinicaltrials.gov/study/NCT02910778)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 32
- **Lead Sponsor:** Medical University of Vienna
- **Conditions:** Ischemia
- **Start Date:** 2016-10
- **Completion Date:** 2017-03
- **CT.gov Last Update:** 2017-03-22

## Brief Summary

To test the effect of atorvastatin or placebo in combination with ticagrelor on ACh-induced vasodilatation of the forearm resistance vasculature as assessed by forearm blood flow (FBF) measurement before and 10 min after a 20 min forearm ischemia. The area under the dose-effect curve (AUC) of different ACh doses will be calculated and compared between treatment groups (atorvastatin + ticagrelor vs. placebo + ticagrelor) and different time points (pre-ischemia vs. post-ischemia).

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 40 Years
- **Sex:** MALE
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Healthy male subjects; 18 - 40 years of age
* Body mass index between 18 and 27 kg/m2
* Written informed consent
* Normal findings in medical \& bleeding history
* Non-smoking

Exclusion Criteria:

* Regular intake of any medication including OTC drugs and herbals within 2 weeks before IMP administration
* Known coagulation disorders (e.g. haemophilia, von Willebrand´s disease)
* Known disorders with increased bleeding risk (e.g. peridontosis, haemorrhoids, acute gastritis, peptic ulcer, intestinal ulcer)
* Known sensitivity to common causes of bleeding (e.g. nasal)
* History of thromboembolism
* History of occlusive vascular diseases
* History of vascular anomalies
* History of hypercholesterolemia
* History of myopathy
* Impaired liver function (AST, ALT, gGT, bilirubin \> 3 x ULN)
* Impaired renal function (serum creatinine \> 1.3 mg/dl)
* Elevated creatinine-kinase or serum-myoglobin (\> 3 x ULN)
* Any other relevant deviation from the normal range in clinical chemistry, haematology or urine analysis
* HIV-1/2-Ab, HbsAg or HCV-Ab positive serology
* Systolic blood pressure above 145 mmHg, diastolic blood pressure above 95 mmHg
* Known allergy against any test agent under study
* Regular daily consumption of more than on litre of xanthine-containing beverages or more than 40g alcohol
* Participation in another clinical trial during the preceding 3 weeks
```

## Arms

- **Atorvastatin** (EXPERIMENTAL) — 80 mg atorvastatin for 14 days with a loading dose of 180 mg ticagrelor on day 15
- **Placebo** (PLACEBO_COMPARATOR) — Placebo for 14 days with a loading dose of 180 mg ticagrelor on day 15

## Interventions

- **Atorvastatin** (DRUG) — Subjects will receive 80 mg atorvastatin once daily for 14 days (until study day 15). On study day 15, 80 mg atorvastatin in combination with a loading dose of 180 mg ticagrelor will be administered.
- **Placebo** (DRUG) — Subjects will receive placebo once daily for 14 days (until study day 15). On study day 15, placebo in combination with a loading dose of 180 mg ticagrelor will be administered.
- **Ticagrelor** (DRUG)

## Primary Outcomes

- **Area under the curve (AUC) of Forearm blood flow (FBF) measurements of Acetylcholine (ACh) induced vasodilatation** _(time frame: Change of the AUC before and 10 min after forearm ischemia)_ — To test the effect of atorvastatin or placebo in combination with ticagrelor on ACh-induced vasodilatation of the forearm resistance vasculature as assessed by FBF measurement before and 10 min after a 20 min forearm ischemia

## Secondary Outcomes

- **Area under the curve (AUC) of Forearm blood flow (FBF) measurements of Glyceryltrinitrate (GTN) induced vasodilatation** _(time frame: Change of the AUC before and 10 min after forearm ischemia)_

## Locations (1)

- Medical University of Vienna, Department of Clinical Pharmacology, Vienna, State of Vienna, Austria

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.medical university of vienna, department of clinical pharmacology|vienna|state of vienna|austria` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT02910778*  
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